http://pharmtech.findpharma.com/pharmtech/Analytics/Article/list/40943 Analytical testing methods in pharma manufacturing. Chromatography, UHPLC, chiral. Near-infrared (NIR) and Raman spectroscopy. Anticounterfeiting. Dissolution testing. Cleaning validation. Extracables & leachables. 2009-11-21T20:24:28Z http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Nov-16-2009-GSK-and-Nabi-Form-Nicotine-Vac/ArticleStandard/Article/detail/642581?contextCategoryId=40943&ref=25 Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more... 2009-11-19T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472009/642581null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Choosing-the-best-construction-material-for-powder/ArticleStandard/Article/detail/641749?contextCategoryId=40943&ref=25 Selecting the best material of construction is a crucial part of the plant design process, the aim being to balance performance and cost to best advantage. For powder processors, choosing a material that eases flow can pay dividends throughout the lifetime of the plant, but there is limited data on which to base this decision. A recent study by Freeman Technology highlights the role of the FT4 universal powder tester for such studies and provides some valuable comparative data for a wide range of commercially available materials and finishes. 2009-11-13T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/641749null REMOTE http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/AAPS-Announces-Annual-Awards-Names-2009-Fellows/ArticleStandard/Article/detail/640909?contextCategoryId=40943&ref=25 The American Association of Pharmaceutical Scientists (AAPS) recognized researchers at the organization's 2009 Annual Meeting and Exposition in Los Angeles this week. 2009-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/640909null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Week-of-Nov-9-2009-Merck-and-Schering-Plough-Begin/ArticleStandard/Article/detail/640959?contextCategoryId=40943&ref=25 Company and People Notes: 3M forms agreement with VaxInnate; TRIN Pharma appoints CEO; More... 2009-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/640959null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/SOCMA-Hails-FDA-Action-on-Citizen-Petition-Regardi/ArticleStandard/Article/detail/639211?contextCategoryId=40943&ref=25 The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639211null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/ICH-Adopts-Pharmacopeial-Text-Annexes-and-Prepares/ArticleStandard/Article/detail/638997?contextCategoryId=40943&ref=25 Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638997null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Nov-2-2009-Eli-Lilly-Opens-Biotech-Center-/ArticleStandard/Article/detail/639212?contextCategoryId=40943&ref=25 Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639212null HTML http://pharmtech.findpharma.com/pharmtech/IT/Stay-Afloat-with-Lessons-Learned/ArticleStandard/Article/detail/639195?contextCategoryId=40943&ref=25 FDA's Edwin Rivera-Martinez on dodging supply-chain challenges. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639195null XML http://pharmtech.findpharma.com/pharmtech/IT/DIY-Healthcare-Reform/ArticleStandard/Article/detail/639194?contextCategoryId=40943&ref=25 While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639194null XML http://pharmtech.findpharma.com/pharmtech/Article/A-Robust-Automated-Karl-Fischer-Titration-System/ArticleStandard/Article/detail/639198?contextCategoryId=40943&ref=25 The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639198/pt-1109-fig-2-p58B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639198null XML http://pharmtech.findpharma.com/pharmtech/IT/In-the-Spotlight/ArticleStandard/Article/detail/639200?contextCategoryId=40943&ref=25 Editors' Picks of Pharmaceutical Science & Technology Innovations 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639200null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Regulatory-Update-The-IPEC-Novel-Excipient-Safety-/ArticleStandard/Article/detail/639204?contextCategoryId=40943&ref=25 The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639204null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Sharing-Supply-Chain-Security/ArticleStandard/Article/detail/639209?contextCategoryId=40943&ref=25 A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209/pt1109_coverstory_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209null XML http://pharmtech.findpharma.com/pharmtech/Analytics/Challenges-and-Strategies-for-Implementing-Automat/ArticleStandard/Article/detail/638760?contextCategoryId=40943&ref=25 The authors used a light-transmission-based static division system to detect particles of foreign contaminants in prefilled vials. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638760/pt-1109supp-p25-fig1B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638760null XML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-26-2009-OXiGENE-to-Acquire-VaxGen-Warn/ArticleStandard/Article/detail/637174?contextCategoryId=40943&ref=25 Also, Astellas and Medivation sign development pact; WuXi PharmaTech appoints VP of business development, more... 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637174null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-19-2009-Lonza-Drops-Bid-for-Patheon-Pe/ArticleStandard/Article/detail/635533?contextCategoryId=40943&ref=25 Company and People Notes: SurModics forms agreement with Roche and Genentech; Hospira names Daphne Jones senior VP and chief information officer; more... 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635533null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-12-2009-GSK-and-Prosensa-Form-Pact-Car/ArticleStandard/Article/detail/633981?contextCategoryId=40943&ref=25 Company and People Notes: Bayer Schering Pharma forms collaboration with Compugen; Takeda San Francisco appoints VP of process science; more... 2009-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422009/633981null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-5-2009-Merck-and-CSL-Sign-Flu-Vaccine-/ArticleStandard/Article/detail/632124?contextCategoryId=40943&ref=25 Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more... 2009-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632124null HTML http://pharmtech.findpharma.com/pharmtech/Article/Getting-the-Truth-out-of-Dissolution-Testing/ArticleStandard/Article/detail/631721?contextCategoryId=40943&ref=25 Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631721/Coverstory_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631721null XML http://pharmtech.findpharma.com/pharmtech/Statistical+Solutions/Square-Root-of-emNem---1-Sampling-Plan/ArticleStandard/Article/detail/631722?contextCategoryId=40943&ref=25 Is the square root of (N) + 1 a statistically valid scheme? 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631722null XML http://pharmtech.findpharma.com/pharmtech/Inside+Standards/Inside-USP-Characterization-of-Heparin-Products/ArticleStandard/Article/detail/632995?contextCategoryId=40943&ref=25 USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632995/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632995null XML http://pharmtech.findpharma.com/pharmtech/IT/PhRMAs-Stake-in-Reform/ArticleStandard/Article/detail/631752?contextCategoryId=40943&ref=25 The nation's healtcare system needs an overhaul, but it has to be done right. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631752null XML http://pharmtech.findpharma.com/pharmtech/Article/Pharma-Capsules/ArticleStandard/Article/detail/631712?contextCategoryId=40943&ref=25 Brief pharmaceutical news items for October 2009. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631712null XML http://pharmtech.findpharma.com/pharmtech/Article/Verification-Methods-for-198-Common-Raw-Materials-/ArticleStandard/Article/detail/631708?contextCategoryId=40943&ref=25 Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631708/72_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631708null XML http://pharmtech.findpharma.com/pharmtech/Special+Section%3A+Quality+by+Design/Academia-Tackles-QbD-Science-NIPTE-Carries-out-FDA/ArticleStandard/Article/detail/632993?contextCategoryId=40943&ref=25 A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632993/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632993/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632993null XML http://pharmtech.findpharma.com/pharmtech/Article/The-Relevance-of-Continuous-Solid-Oral-Dosage-Proc/ArticleStandard/Article/detail/631713?contextCategoryId=40943&ref=25 The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631713/112_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631713null XML http://pharmtech.findpharma.com/pharmtech/IT/Looking-Ahead-The-Pharmaceutical-Science-Industry/ArticleStandard/Article/detail/631750?contextCategoryId=40943&ref=25 AAPS President offers hope and solutions for the industry's challenging future. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631750null XML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-28-2009-JampJ-and-Crucell-Enter-Colla/ArticleStandard/Article/detail/630279?contextCategoryId=40943&ref=25 Company and People Notes: Boehringer Ingelheim will acquire Wyeth's animal health business; Amsterdam Molecular Therapeutics appoints CEO; more... 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/630279null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Bayer-Receives-Warning-Letter-for-Alleged-Deviatio/ArticleStandard/Article/detail/628581?contextCategoryId=40943&ref=25 The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs). 2009-09-24T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392009/628581null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-21-2009-AstraZeneca-and-Nektar-Sign-L/ArticleStandard/Article/detail/628576?contextCategoryId=40943&ref=25 Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more... 2009-09-24T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392009/628576null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-14-2009-Evotec-and-Biogen-Idec-Form-P/ArticleStandard/Article/detail/626906?contextCategoryId=40943&ref=25 Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more... 2009-09-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382009/626906null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Implementing-QbD-Powder-characterization-for-desig/ArticleStandard/Article/detail/625969?contextCategoryId=40943&ref=25 For those seeking to adopt a Quality by Design approach to pharmaceutical development and manufacture, effective definition of the 'design space' is a key activity. This paper considers the role of modern powder testers such as the FT4 from Freeman Technology, within this context. 2009-09-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/625969null REMOTE http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-7-2009-Facet-Rejects-Biogen-Idecs-Pro/ArticleStandard/Article/detail/624922?contextCategoryId=40943&ref=25 Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more... 2009-09-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624922null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Week-of-Aug-31-2009-Roche-Purchases-Lonza-Facility/ArticleStandard/Article/detail/623587?contextCategoryId=40943&ref=25 Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more... 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623587null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Inside-IPECndashAmericas-Evaluating-Excipient-Stab/ArticleStandard/Article/detail/624205?contextCategoryId=40943&ref=25 IPEC's new stability testing guide takes into account the full supply chain's storage conditions. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624205null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Pharma-Capsules/ArticleStandard/Article/detail/625569?contextCategoryId=40943&ref=25 Brief pharmaceutical news items for September 2009. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/625569null XML http://pharmtech.findpharma.com/pharmtech/IT/The-GoNo-Go-Mindset/ArticleStandard/Article/detail/624651?contextCategoryId=40943&ref=25 As new process validation guidelines emerge, industry needs to reinvent how it releases product. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624651null XML http://pharmtech.findpharma.com/pharmtech/IT/Quality-by-Enforcement/ArticleStandard/Article/detail/624202?contextCategoryId=40943&ref=25 After years of promomting QbD concepts, FDA's ready to take action on nonconformers. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624202null XML http://pharmtech.findpharma.com/pharmtech/Peer-Reviewed+Research/The-benefits-of-risk-based-analyses-during-system-/ArticleStandard/Article/detail/621294?contextCategoryId=40943&ref=25 When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621294/Woods_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621294null XML http://pharmtech.findpharma.com/pharmtech/Whitepapers/A-Tale-of-Two-Thermals/ArticleStandard/Article/detail/622361?contextCategoryId=40943&ref=25 Part one of the three?part core technology white paper series discusses the principle of operations of capillary thermal and immersible thermal gas mass flow measurement technologies. Taken together, these two methods cover a wide spectrum of gas mass flow measurements typically found in industrial applications. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/622361null REMOTE http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Aug-24-2009-Warner-Chilcott-Buys-PampG-Pha/ArticleStandard/Article/detail/621551?contextCategoryId=40943&ref=25 Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more... 2009-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621551null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/NIR-Prediction-of-Solid-Dosage-Form-Dissolution-Pr/ArticleStandard/Article/detail/621674?contextCategoryId=40943&ref=25 It can be concluded from this study that Near-Infrared (NIR) prediction of dissolution profiles of intact tablets provides a fast and accurate means of non-destructively assessing tablets that is in step with the FDA Process Analytical Technology (PAT) initiatives. The data showed promising results that could relieve laboratory workload from dissolution testing. NIR was able to predict dissolution profiles for tablets with different levels of acetyltributyl citrate (ATBC) closely replicating the error of the lab method. 2009-08-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621674null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/In-Situ-Monitoring-of-Osmolality-and-pH-in-Bioreac/ArticleStandard/Article/detail/621669?contextCategoryId=40943&ref=25 Near-Infrared Spectroscopy (NIRS) can monitor a bioreactor in situ and in real time, so it is capable of replacing or supplementing osmolality and pH measurements off-line or current on-line pH methods. NIRS may be used to improve cell viability and productivity with closed-loop feedback. 2009-08-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621669null REMOTE http://pharmtech.findpharma.com/pharmtech/Analytics/Extending-Calibrations-for-Near-Infrared-Assay-of-/ArticleStandard/Article/detail/621672?contextCategoryId=40943&ref=25 The range of a Near-Infrared (NIR) calibration model for tablet assay was extended using production "seed" spectra and synthetic spectra generated from placebos and "pure" API spectra. This method resolves the problem of not being able to obtain a range of production samples with +/- 15% of the label claim of API concentration online. 2009-08-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621672null REMOTE http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Forest-Labs-and-AstraZene/ArticleStandard/Article/detail/620144?contextCategoryId=40943&ref=25 Also, XCELERON and GSK form agreement; Millipore appoints VP of life sciences; more... 2009-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342009/620144null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Nabi-and-GSK-Form-Pact-Ca/ArticleStandard/Article/detail/618405?contextCategoryId=40943&ref=25 Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more... 2009-08-13T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332009/618405null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Near-Infrared-Assay-and-Content-Uniformity-of-Tabl/ArticleStandard/Article/detail/523511?contextCategoryId=40943&ref=25 Near-Infrared (NIR) technique for the determination of content uniformity of tablets provides a fast and accurate means of monitoring tablet production that is in step with the FDA Process Analytical Technology (PAT) initiatives. The FOSS XDS MasterLab™ was used to determine the content uniformity of tablets, instrument precision and accuracy. The data showed promising results that could relieve laboratory workload from HPLC analysis and bring analysis closer to "real-time" for process monitoring. 2009-08-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523511null REMOTE http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Cherokee-and-DuPont-Form-/ArticleStandard/Article/detail/616603?contextCategoryId=40943&ref=25 Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more... 2009-08-06T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322009/616603null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/EMEA-and-FDA-To-Collaborate-on-Good-Clinical-Pract/ArticleStandard/Article/detail/616595?contextCategoryId=40943&ref=25 The US Food and Drug Administration and European Medicines Agency (EMEA) launched this week a joint initiative to collaborate on international good clinical practice (GCP) inspection activities. 2009-08-06T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322009/616595null HTML http://pharmtech.findpharma.com/pharmtech/IT/For-Biotherapeutics-Innovation-is-Not-Enough/ArticleStandard/Article/detail/615816?contextCategoryId=40943&ref=25 Biotech firms must first close the gaps between science and biology on the path toward QbD. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615816null XML http://pharmtech.findpharma.com/pharmtech/Analytics+Article/A-Dubious-Foundation-for-Quality-Control/ArticleStandard/Article/detail/615814?contextCategoryId=40943&ref=25 The author of an ambitious book about quality control falls short of reaching his goals. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615814/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615814null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Pharma-Capsules/ArticleStandard/Article/detail/615826?contextCategoryId=40943&ref=25 Brief pharmaceutical news items for August 2009. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615826null XML http://pharmtech.findpharma.com/pharmtech/Analytics+Article/Comparison-of-Authentic-and-Suspect-Pharmaceutical/ArticleStandard/Article/detail/615820?contextCategoryId=40943&ref=25 The authors applied near-infrared (NIR) spectrophotometry to assess whether eight drug products were authentic or counterfeit. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615820null XML http://pharmtech.findpharma.com/pharmtech/IT/In-the-Spotlight/ArticleStandard/Article/detail/615818?contextCategoryId=40943&ref=25 Editors' Picks of Pharmaceutical Science & Technology Innovations 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615818null XML http://pharmtech.findpharma.com/pharmtech/IT/Of-Hubris-and-Happy-Endings/ArticleStandard/Article/detail/615813?contextCategoryId=40943&ref=25 Individuals and companies at the top seem to have no problem short-circuiting their success. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615813null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Outsourcing-Stability-Studies/ArticleStandard/Article/detail/615513?contextCategoryId=40943&ref=25 The author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies. 2009-08-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615513null XML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Personalized-Medicine-May-Lead-to-More-Mergers/ArticleStandard/Article/detail/614823?contextCategoryId=40943&ref=25 The number of alliances between diagnostics companies and pharmaceutical companies is set to rise because of the growth of personalized medicine, according to a report from PricewaterhouseCoopers. 2009-07-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614823null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-People-and-Regulatory-Notes-Amgen-and-GSK-/ArticleStandard/Article/detail/614815?contextCategoryId=40943&ref=25 Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more... 2009-07-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614815null HTML http://pharmtech.findpharma.com/pharmtech/News/Final-Guidance-on-Listing-Drug-Substance-Impuritie/ArticleStandard/Article/detail/612969?contextCategoryId=40943&ref=25 The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances. 2009-07-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302009/612969null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-People-and-Regulatory-Briefs-Teva-and-Orth/ArticleStandard/Article/detail/612961?contextCategoryId=40943&ref=25 Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more... 2009-07-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302009/612961null HTML http://pharmtech.findpharma.com/pharmtech/Article/The-Debate-over-Preuse-Filter-Integrity-Testing/ArticleStandard/Article/detail/612612?contextCategoryId=40943&ref=25 Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity testing provides evidence that a filter will perform correctly, has the right pore size, and has been installed correctly. 2009-07-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302009/612612null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Merck-and-Portola-Sign-Ag/ArticleStandard/Article/detail/611109?contextCategoryId=40943&ref=25 Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more... 2009-07-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292009/611109null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Better-Wet-Granulation-Development-Scale-Up-and-Ma/ArticleStandard/Article/detail/610802?contextCategoryId=40943&ref=25 Wet granulation is a common unit operation in the pharmaceutical industry, yet accurate endpoint detection remains a challenge. The author examines the contribution that dynamic powder rheometry can make, highlighting its ability to detect the transition from wet mass to granulate with the required sensitivity. Quantification of this transition point, with a measure that is independent of process scale, accelerates development and scale-up and improves manufacture. 2009-07-13T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292009/610802null REMOTE http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Pfizer-and-Graceway-Form-/ArticleStandard/Article/detail/609491?contextCategoryId=40943&ref=25 Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more... 2009-07-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282009/609491null HTML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling+Article/Pharma-Capsules/ArticleStandard/Article/detail/607457?contextCategoryId=40943&ref=25 Brief pharmaceutical news items for July 2009. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607457null XML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-and-Chroma-Form-Devel/ArticleStandard/Article/detail/607999?contextCategoryId=40943&ref=25 Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more... 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607999null HTML http://pharmtech.findpharma.com/pharmtech/IT/The-Good-Society/ArticleStandard/Article/detail/607467?contextCategoryId=40943&ref=25 Is it good policy to pay for bad behavior? 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607467null XML http://pharmtech.findpharma.com/pharmtech/Manufacturing/USP-Collaborates-with-Asian-Authorities/ArticleStandard/Article/detail/608009?contextCategoryId=40943&ref=25 This week, the US Pharmacopeial Convention and the Vietnamese Pharmacopoeia Commission signed a memorandum of understanding that will help ensure the safety of Vietnamese medicines. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608009null HTML http://pharmtech.findpharma.com/pharmtech/Analytics+Article/Cleaning-Verification-Method-Development-and-Valid/ArticleStandard/Article/detail/608708?contextCategoryId=40943&ref=25 The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608708/Galella1_rotate_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Less-Is-More-for-Low-Dose-Drugs/ArticleStandard/Article/detail/607458?contextCategoryId=40943&ref=25 Developers of low-dose drugs in solid oral dosage forms will find theoretical considerations and practical advice in a new book. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607458/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607458null XML http://pharmtech.findpharma.com/pharmtech/IT/Can-Industry-Learn-to-Share/ArticleStandard/Article/detail/607463?contextCategoryId=40943&ref=25 The regulators are doing it. But industry's fear of sharing information may leave them behind. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607463null XML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Aqueous-Cleaning-for-Pharmaceutical-Applications/ArticleStandard/Article/detail/476613?contextCategoryId=40943&ref=25 To streamline regulatory compliance, the desirability of using as few cleaners as possible to remove the entire range of residues encountered in pharmaceutical manufacturing — from water-soluble excipients to difficult-to-clean petrolatum/metal oxide mixtures — is explored in the standard industry text, The Aqueous Cleaning Handbook. Cleaning validation guidelines and key factors in establishing sound GMP and cGMP procedures are discussed. Explaining how aqueous cleaners work in a wide range of cleaning procedures, the text covers manual, soak and ultrasonic cleaning as well as clean-in-place (CIP) spray systems. Tables for chemical formulations, types of cleaning methods, and aqueous cleaning agents are included. A useful, in-depth reference whether you are cleaning bench scale lab apparatus used for trials to full-scale bulk manufacturing equipment. 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/482007/476613null REMOTE http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Synta-and-GSK-End-Agreeme/ArticleStandard/Article/detail/606500?contextCategoryId=40943&ref=25 Also, Adimab forms deals with Merck and Roche; Manhattan Pharmaceuticals' CEO and president steps down; more... 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/606500null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Dr-Reddy-and-GSK-Form-Pac/ArticleStandard/Article/detail/604472?contextCategoryId=40943&ref=25 Also, FDA debars clinical investigators; Jubilant Organosys forms deal with Endo Pharmaceuticals; AMRI makes changes to its India management team; more... 2009-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/604472null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-CSL-and-Talecris-Terminat/ArticleStandard/Article/detail/602720?contextCategoryId=40943&ref=25 Also, TorreyPines Therapeutics to liquidate assets and dissolve company; EU's competition services to examine Pfizer/Wyeth merger; Akorn appoints Raj Rai interim CEO; more... 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602720null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-AstraZeneca-and-Merck-Col/ArticleStandard/Article/detail/601645?contextCategoryId=40943&ref=25 Also, WACKER expands Iowa facility; EMEA releases a Q&A document for PIPs; Metrics consolidates quality operations; more... 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601645null HTML http://pharmtech.findpharma.com/pharmtech/IT/Beneath-the-Surface/ArticleStandard/Article/detail/600812?contextCategoryId=40943&ref=25 It can take a lot of work to make sure nothing happens. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600812null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Initial-Solvent-Screening-of-Carbamazepine-Cimetid/ArticleStandard/Article/detail/601168?contextCategoryId=40943&ref=25 The authors describe the importance of a rapid and an abbreviated screening strategy in initial solvent screening. This article contains bonus online-exclusive material. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601168/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601168null XML http://pharmtech.findpharma.com/pharmtech/IT/Quality-in-Quality-Out/ArticleStandard/Article/detail/601167?contextCategoryId=40943&ref=25 A book guides readers through the regulatory requirements for computerized quality systems. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601167/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601167null XML http://pharmtech.findpharma.com/pharmtech/IT/Truth-and-Transparency/ArticleStandard/Article/detail/600808?contextCategoryId=40943&ref=25 Misleading the public about their investments—be it money or medicine—is unacceptable. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600808null XML http://pharmtech.findpharma.com/pharmtech/Analytics+Article/Charting-a-Pathway-to-Follow-On-Biologics/ArticleStandard/Article/detail/600817?contextCategoryId=40943&ref=25 Debates about science, manufacturing, and European regulations will shape the approval process for follow-on biologics in the United States. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600817/rotate_cover_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Static-Electricity-The-Hidden-Danger/ArticleStandard/Article/detail/600996?contextCategoryId=40943&ref=25 Static Electricity is an ever-present hazard for operations and processes taking place in flammable or combustible locations. Sparking caused by electrostatic can provide an ignition source for gases, vapors and dust atmospheres. This article explains the background to the hazards of static electricity and provides some guidance as to how they may be safely avoided. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/600996null REMOTE http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Pfizer-Forms-Licensing-Ag/ArticleStandard/Article/detail/600299?contextCategoryId=40943&ref=25 Also, Johnson & Johnson acquires Cougar Biotechnology; NIH launches program for rare and neglected diseases; PPD restructures leadership positions; more... 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600299null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Teva-and-Lonza-Joint-Vent/ArticleStandard/Article/detail/599148?contextCategoryId=40943&ref=25 Also, Oxford BioTherapeutics forms drug development pact with GSK; Avila Therapeutics names CEO; more... 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599148null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-Forms-Pact-with-Aspen/ArticleStandard/Article/detail/598063?contextCategoryId=40943&ref=25 Also, Takeda to consolidate operations in Ireland; FDA to redesign website; Archemix names president and CEO; more... 2009-05-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/598063null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Requests-Largest-Ever-Budget-Increase/ArticleStandard/Article/detail/597992?contextCategoryId=40943&ref=25 On May 7, 2009, as part of the President's fiscal year (FY) 2010 budget, the US Food and Drug Administration requested a budget of $3.2 billion, which is 19% more than the agency's current budget. 2009-05-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/597992null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Jubilant-Biosys-Forms-Pac/ArticleStandard/Article/detail/597076?contextCategoryId=40943&ref=25 Also, Oxford BioMedica forms collaboration with sanofi-aventis; FDA requires labeling changes for botulinum toxin producs; C. Richter King joins IAVI; more... 2009-05-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192009/597076null HTML http://pharmtech.findpharma.com/pharmtech/IT/Shop-Floor-and-Top-Floor-Unite/ArticleStandard/Article/detail/596049?contextCategoryId=40943&ref=25 Technology can solve enterprise-level problems. 2009-05-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/182009/596049null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Easing-the-Bottleneck/ArticleStandard/Article/detail/596044?contextCategoryId=40943&ref=25 Manufacturers of therapeutic monoclonal antibodies consider new paradigms in purification technologies. 2009-05-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/182009/596044/RotateCover_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Initial-Solvent-Screening-of-Carbamazepine-Cimetid/ArticleStandard/Article/detail/596429?contextCategoryId=40943&ref=25 The authors describe the importance of a rapid and an abbreviated screening strategy by initial solvent screening in 20-mL scintillation vials. 2009-05-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192009/596429null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Industry-Leaders-Debate-Follow-on-Biologics-Pathwa/ArticleStandard/Article/detail/596043?contextCategoryId=40943&ref=25 The organizations' presidents discuss market exclusivity, approval processes, and pending legislation. 2009-05-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/182009/596043null XML http://pharmtech.findpharma.com/pharmtech/IT/Biotechnology-in-2009/ArticleStandard/Article/detail/596053?contextCategoryId=40943&ref=25 The president of BIO proposes the ingredients needed for industry growth. 2009-05-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/182009/596053null XML http://pharmtech.findpharma.com/pharmtech/Analytics+Article/Identification-of-Fungi-Using-Ribosomal-Internal-T/ArticleStandard/Article/detail/595863?contextCategoryId=40943&ref=25 Identification of fungi, especially filamentous fungi, has been a very difficult task. Because of the amount of experience required to accurately identify filamentous fungi to the species level, it has become acceptable to either identify these organisms to the genus level or, in some cases, simply identify them as "molds." 2009-05-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/182009/595863null XML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-CIGNA-and-Merck-Agree-on-/ArticleStandard/Article/detail/595723?contextCategoryId=40943&ref=25 Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more... 2009-04-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/182009/595723null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/FDA-Answers-Key-Residual-Solvent-Testing-Questions/ArticleStandard/Article/detail/595618?contextCategoryId=40943&ref=25 The US Food and Drug Administration has agreed to address some core industry questions regarding the changes made to US Pharmacopeia General Chapter <467> in July 2008. 2009-04-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/182009/595618null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/FDA-Issues-Guidance-on-Summaries-for-CTD-based-Sub/ArticleStandard/Article/detail/594586?contextCategoryId=40943&ref=25 The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD). 2009-04-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/172009/594586null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Company-and-People-Notes-GSK-Acquires-Stiefel-Labo/ArticleStandard/Article/detail/594648?contextCategoryId=40943&ref=25 Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more... 2009-04-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/172009/594648null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-DSM-and-Shire-Form-Pact-P/ArticleStandard/Article/detail/593691?contextCategoryId=40943&ref=25 Also, Sanofi-aventis acquires Medley and Laboratorios Kendrick; Eli Lilly's Cook to retire from board; more... 2009-04-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/162009/593691null HTML http://pharmtech.findpharma.com/pharmtech/Formulation/USP-Forms-Collaboration-with-Russia/ArticleStandard/Article/detail/593447?contextCategoryId=40943&ref=25 The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow. 2009-04-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/162009/593447null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Pfizer-to-Divide-Research-Activities-into-Two-Bran/ArticleStandard/Article/detail/592339?contextCategoryId=40943&ref=25 Pfizer outlined the progress of its late-stage pipeline last week and announced this week plans to separate its research activities into two organizations, one focused on small molecules and the other on biologics, pending the closure of its pending acquisition with Wyeth. 2009-04-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/152009/592339null HTML