http://pharmtech.findpharma.com/pharmtech A publication providing practical information on pharmaceutical manufacturing. Content focuses on applied R&D technology, process control and computer-integrated manufacturing, biotechnology and technical management. 2009-11-07T15:57:08Z http://pharmtech.findpharma.com/pharmtech/Sizing-Up-the-CDMO-Market/ArticleStandard/Article/detail/639786?ref=25 A new analysis highlights growth drivers and challenges for clinical supply-chain services. 2009-11-10T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639786null XML http://pharmtech.findpharma.com/pharmtech/SOCMA-petition-reveals-disparity-of-FDA-inspection/ArticleStandard/Article/detail/639161?ref=25 The FDA has responded to a citizen petition from the Society of Chemical Manufacturers and Affiliates (SOCMA) that highlighted the disparity in inspections of domestic and foreign drug-manufacturing facilities. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639161null HTML http://pharmtech.findpharma.com/pharmtech/Illegal-equipment-puts-pharma-workers-in-danger/ArticleStandard/Article/detail/639158?ref=25 The prevalence of substandard or counterfeit safety products and personal protective equipment (PPE) has become a "very serious" problem in the UK, according to the British Safety Industry Federation (BSIF), and could be putting workers in the pharma industry at risk. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639158null HTML http://pharmtech.findpharma.com/pharmtech/10-new-orphan-products-a-year-between-2009-and-201/ArticleStandard/Article/detail/639157?ref=25 The European Organisation for Rare Diseases (EURORDIS) has predicted that 100 new designated orphan products will receive marketing authorization between 2009 and 2019, which equates to approximately 10 new products every year. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639157null HTML http://pharmtech.findpharma.com/pharmtech/New-biopharm-pumps-with-extensive-documentation-pa/ArticleStandard/Article/detail/639925?ref=25 Alfa Laval has added two new biopharm pumps to its offering and can now meet a wider selection of customer needs at differentiated prices. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639925null HTML http://pharmtech.findpharma.com/pharmtech/Lonza-plans-cost-reductions/ArticleStandard/Article/detail/639163?ref=25 Lonza (Switzerland) has announced a series of cost-cutting measures for the next 12¬–18 months. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639163null HTML http://pharmtech.findpharma.com/pharmtech/Novartis-to-invest-1-billion-in-China-RampD-instit/ArticleStandard/Article/detail/639159?ref=25 Novartis (Switzerland) plans to invest $1 billion during the next 5 years to increase R&D activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639159null HTML http://pharmtech.findpharma.com/pharmtech/Broken-biopharm/ArticleStandard/Article/detail/639155?ref=25 The engine of biopharmaceutical innovation is broken, according to Eli Lilly's Chairman and CEO, John C. Lechleiter. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639155null HTML http://pharmtech.findpharma.com/pharmtech/New-speciality-pharma-company-formed-in-Sweden/ArticleStandard/Article/detail/639927?ref=25 A new pharmaceutical company with a focus on rare diseases has been formed in Sweden following the merger of the Swedish companies Biovitrum and Swedish Orphan. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639927null HTML http://pharmtech.findpharma.com/pharmtech/New-biopharm-portal-brings-clarity-to-equipment-GM/ArticleStandard/Article/detail/639915?ref=25 A site designed to take the mystery out of biopharm equipment selection, GMP concepts and good engineering practice. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639915null HTML http://pharmtech.findpharma.com/pharmtech/USP-revises-excipient-standards-to-limit-contamina/ArticleStandard/Article/detail/639165?ref=25 In response to a request from the FDA, the US Pharmacopeial Convention (USP) has revised its standards for propylene glycol and sorbitol solution, excipients widely used in prescription and over-the-counter drugs. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639165null HTML http://pharmtech.findpharma.com/pharmtech/ICH-prepares-for-global-quality-implementation/ArticleStandard/Article/detail/639164?ref=25 The International Conference on Harmonization (ICH) has adopted pharmacopeial text annexes after a meeting of the steering committee and expert working groups last week. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639164null HTML http://pharmtech.findpharma.com/pharmtech/Light-activated-gold-cage-delivery-capsule-develop/ArticleStandard/Article/detail/639156?ref=25 A smart nanocage that can be filled with a medicinal substance and then activated using light has been developed by US researchers. 2009-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639156null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Issues-Guidance-on-In-Vitro/ArticleStandard/Article/detail/639001?ref=25 Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639001null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Novartis-To-Invest-1-Billion-in-China-RampD-Instit/ArticleStandard/Article/detail/638992?ref=25 Novartis (Basel, Switzerland) plans to invest $1 billion over the next five years to increase research and development activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638992null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/SOCMA-Hails-FDA-Action-on-Citizen-Petition-Regardi/ArticleStandard/Article/detail/639211?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?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/Formulation/USP-Revises-Excipient-Standards-to-Limit-Contamina/ArticleStandard/Article/detail/639036?ref=25 In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639036null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Nov-2-2009-Eli-Lilly-Opens-Biotech-Center-/ArticleStandard/Article/detail/639212?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/Manufacturing/Europe-May-See-10-New-Orphan-Products-a-Year/ArticleStandard/Article/detail/638999?ref=25 The European Organization for Rare Diseases (EURORDIS) predicts that 100 new designated orphan products will receive marketing authorization between 2009 and 2019, which equates to approximately 10 new products every year. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638999null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Lonza-Restructures-Plans-Cost-Reductions/ArticleStandard/Article/detail/639210?ref=25 Lonza (Basel, Switzerland), the large contract manufacturer of small-molecule and biologic-based active pharmaceutical ingredients (APIs), announced last week a series of cost-cutting measures for the next 12 to 18 months. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639210null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Advancing-Chiral-Chemistry-in-API-Synthesis/ArticleStandard/Article/detail/639207?ref=25 Functionalized supramolecular catalysts and an enantioselective route to unnatural amino acids are some recent developments. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639207/pt-1109-p44-Ingredients_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639207null XML http://pharmtech.findpharma.com/pharmtech/IT/Stay-Afloat-with-Lessons-Learned/ArticleStandard/Article/detail/639195?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/Ingredients/Regulatory-Update-The-IPEC-Novel-Excipient-Safety-/ArticleStandard/Article/detail/639204?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/Whatever-Happened-to-Classical-Chemistry/ArticleStandard/Article/detail/639203?ref=25 A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639203/pt-1109-Vetterlein-book-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639203/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639203null XML http://pharmtech.findpharma.com/pharmtech/Article/Safety-versus-Speed-in-Drug-Development/ArticleStandard/Article/detail/639197?ref=25 The heightened focus on risk raises concerns about delays in approving new drugs. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639197null XML http://pharmtech.findpharma.com/pharmtech/Article/Report-from-the-Philippines/ArticleStandard/Article/detail/639208?ref=25 New pricing controls and healthcare reforms may be pushing the pharmaceutical market out of this southeast Asian country. This article contains bonus online-exclusive material. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639208/pt-1109-Philippines-p18_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639208/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639208null XML http://pharmtech.findpharma.com/pharmtech/Industry+Leaders/Hans-Engels-of-DSM-Pharmaceuticals/ArticleStandard/Article/detail/639989?ref=25 Engels discusses the latest industry developments and trends. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639989/P90.-Q&A_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639989null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Facing-Reality/ArticleStandard/Article/detail/639202?ref=25 Contract organizations waiting for the pipeline to come roaring back are kidding themselves. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639202null XML http://pharmtech.findpharma.com/pharmtech/Article/Are-We-Abandoning-IQ-and-OQ/ArticleStandard/Article/detail/639193?ref=25 New standards may overlook critical qualification needs. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639193null XML http://pharmtech.findpharma.com/pharmtech/Article/Position-Paper-Are-We-Abandoning-IQ-and-OQ/ArticleStandard/Article/detail/639199?ref=25 The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment." 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639199/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639199null XML http://pharmtech.findpharma.com/pharmtech/Article/A-Robust-Automated-Karl-Fischer-Titration-System/ArticleStandard/Article/detail/639198?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/whitepaper-alert/ArticleStandard/Article/detail/638549?ref=25 white paper alert 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638549null PDF http://pharmtech.findpharma.com/pharmtech/esolution-broadcast-2/ArticleStandard/Article/detail/638542?ref=25 esolution broadcast 2 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638542null PDF http://pharmtech.findpharma.com/pharmtech/Article/Changes-for-Better-or-Worse/ArticleStandard/Article/detail/639201?ref=25 New tests solve one issue, but cheaper plastic and new stoppers cause problems. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639201null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Sharing-Supply-Chain-Security/ArticleStandard/Article/detail/639209?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/Article/Moisture-Activated-Dry-GranulationmdashPart-I-A-Gu/ArticleStandard/Article/detail/639196?ref=25 The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639196/pt1109-fig-1-P64B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639196null XML http://pharmtech.findpharma.com/pharmtech/IT/DIY-Healthcare-Reform/ArticleStandard/Article/detail/639194?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/Inside+Standards/Insider-Solutions-A-New-Direction-for-USP/ArticleStandard/Article/detail/639205?ref=25 With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639205null XML http://pharmtech.findpharma.com/pharmtech/IT/In-the-Spotlight/ArticleStandard/Article/detail/639200?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/Industry+Leaders/Preventing-counterfeits-from-entering-the-supply-c/ArticleStandard/Article/detail/635815?ref=25 With counterfeit drugs on the rise, the Chairman and CEO of Ahura Scientific discusses the issue and explains how a handheld device is helping companies to tackle the problem. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635815/doug_thumbnail_thumbnail.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635815null HTML http://pharmtech.findpharma.com/pharmtech/News/ArticleStandard/Article/detail/637631?ref=25 A round-up of news from across the industry. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637631null XML http://pharmtech.findpharma.com/pharmtech/Industry+Leaders/A-novel-drug-detection-technology/ArticleStandard/Article/detail/631248?ref=25 Researchers at the University of Leicester (UK) have combined crime research and space-age technology to create a new method of detecting counterfeit pharmaceuticals. The technique, Spectral ID, works by detecting the differences between the characteristics of light reflected from printed packaging. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631248null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Sustainability-in-the-packaging-supply-chain/ArticleStandard/Article/detail/631118?ref=25 Michael Rubenstein, Chief Growth and Innovation Officer at Alcan Packaging, talks about applying a philosophy of sustainability to the pharmaceutical packaging supply chain. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/631118null HTML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/Trends-in-labelling/ArticleStandard/Article/detail/637632?ref=25 Following years of development, DataMatrix codes are now a viable labelling solution for pharma manufacturers. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637632/Beauchamp_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637632null XML http://pharmtech.findpharma.com/pharmtech/IT/Simplifying-data-management/ArticleStandard/Article/detail/637637?ref=25 Paper is no longer a sufficient format for information storage and interchange in the pharmaceutical industry; documents are inflexible and costly for production and storage. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637637null XML http://pharmtech.findpharma.com/pharmtech/Peer-Reviewed+Research/Developing-a-modified-Pulsincap-system/ArticleStandard/Article/detail/637638?ref=25 Chronotherapeutic drug delivery systems (CRDDS) have been recognized as potentially beneficial to the chronotherapy (timeoptimized therapy) of widespread chronic diseases that display time-dependent symptoms. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637638/Patel_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637638null XML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Case-study-printing-powders-with-Sticky-Web-techno/ArticleStandard/Article/detail/637639?ref=25 GlaxoSmithKline (GSK) appointed 42 Technology (42T) to evaluate existing powder dispensing approaches that could be scaled for high speed manufacturing. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637639/CaseStudy_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Regulatory-challenges-of-inhaler-testing/ArticleStandard/Article/detail/636406?ref=25 Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636406/mark_thumbnail_thumbnail.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636406null HTML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/Packaging-the-experts-view/ArticleStandard/Article/detail/637634?ref=25 What trends have you witnessed in the pharmaceutical packaging industry in the last 2 years? 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637634/Q&A_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637634null XML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Demographic-time-bomb/ArticleStandard/Article/detail/637635?ref=25 Population ageing is an issue often discussed in the media, but its impact on all facets of life has been poorly characterized. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637635null XML http://pharmtech.findpharma.com/pharmtech/Industry+Leaders/Neal-Dunkinson-151-Up-to-date-business-planning/ArticleStandard/Article/detail/634870?ref=25 Neal Dunkinson, Commercial Development Manager at CMR International, Thomson Reuters talks about the 2009 Edition of the CMR International Pharmaceutical R&D Factbook. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/634870/thumbnail_thumbnail.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/634870null HTML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/Plastic-Prefilled-Syringes-A-Better-Fit-for-Autoin/ArticleStandard/Article/detail/638757?ref=25 The authors describe the ways in which plastic prefilled syringes can be an alternative that provides consistent performance, protects drugs prone to degradation, and enhances patient safety. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638757/pt-1109-sup-fig-1-p7B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638757null XML http://pharmtech.findpharma.com/pharmtech/Change-presents-an-opportunity-for-new-partnership/ArticleStandard/Article/detail/635590?ref=25 A meeting was recently held in Lindau, Germany, to discuss the changing face of pharma and biotech, and how companies can best prepare to face the challenges ahead. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635590/vetter_image_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635590null HTML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/The-pharmaceutical-packaging-market/ArticleStandard/Article/detail/637640?ref=25 According to a survey conducted by Pharmaceutical Technology Europe (PTE), almost 50% of you believe that cost is the biggest limiting factor to innovation in the pharmaceutical packaging industry. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637640/OpenArticle_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637640null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing/Reality-not-insanity/ArticleStandard/Article/detail/637636?ref=25 Apopular definition of insanity is repeating the same task over and over again while expecting a different result. It would appear, therefore, that many people in the contract services industry think the major global bio/pharma companies are insane. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637636null XML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/From-Needle-to-Pill-Reformulating-Injectable-Drugs/ArticleStandard/Article/detail/638762?ref=25 The author describes how Merrion Pharmaceuticals reformulates parenteral drugs into tablets and capsules that are easier for patients to take and provide better bioavailability. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638762/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638762null XML http://pharmtech.findpharma.com/pharmtech/Regulation/USPs-Ferrules-and-Caps-Labeling-Changes-Put-on-Hol/ArticleStandard/Article/detail/638764?ref=25 This article provides an update to the author's Viewpoint column, "Changes to Vial Labels May Affect Patient Safety," which ran in Pharmaceutical Technology's March 2009 issue. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638764/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638764null XML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Risk-Management-for-Aseptic-Processing/ArticleStandard/Article/detail/638758?ref=25 The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638758/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638758null XML http://pharmtech.findpharma.com/pharmtech/Analytics/Challenges-and-Strategies-for-Implementing-Automat/ArticleStandard/Article/detail/638760?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/Peter-Soelkner-of-Vetter/ArticleStandard/Article/detail/635816?ref=25 Peter Soelkner discusses Vetter?s commitment to its clients and the 2nd Vetter Drug Management Leadership Conference, 23–24 September 2009, Lindau, Germany. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635816null HTML http://pharmtech.findpharma.com/pharmtech/Industry+Leaders/Is-EU-pharma-ready-for-Braille-embossing/ArticleStandard/Article/detail/634891?ref=25 In 2010, Braille embossing will be required on all European pharmaceutical packages. Is the industry ready? 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/634891/CraigJasper_thumb_thumbnail.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/634891null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Technology-Forecast-for-Injectables/ArticleStandard/Article/detail/638759?ref=25 A Conversation with Greystone Associates' George Perros. This article contains bonus online-exclusive material. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638759/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638759/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638759null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Targeting-Therapeutics-for-the-Middle-and-Inner-Ea/ArticleStandard/Article/detail/638761?ref=25 A Conversation with Otonomy 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638761/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638761null XML http://pharmtech.findpharma.com/pharmtech/Formulation/Current-Perspectives-on-Aseptic-Formulations/ArticleStandard/Article/detail/638763?ref=25 The author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638763/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638763null XML http://pharmtech.findpharma.com/pharmtech/Editor%27s+comment/Have-your-say/ArticleStandard/Article/detail/637630?ref=25 November is finally upon us and the days are getting colder and shorter. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637630null XML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Optimizing-drug-delivery-to-the-lungs/ArticleStandard/Article/detail/637068?ref=25 An inhaler mouthpiece that optimizes drug delivery to the lungs and reduces the amount of wasted medication has been developed by US researchers. 2009-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637068null HTML http://pharmtech.findpharma.com/pharmtech/Report-calls-out-FDAs-poor-oversight-of-accelerate/ArticleStandard/Article/detail/637071?ref=25 The FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a report from the Government Accountability Office (GAO). 2009-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637071null HTML http://pharmtech.findpharma.com/pharmtech/US-Chemical-manufacturers-raise-concerns-over-mand/ArticleStandard/Article/detail/637073?ref=25 The House Energy and Commerce Committee has approved H.R. 2868, the "Chemical Facility Anti-Terrorism Act of 2009", a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards (CFATS) programme. 2009-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637073null HTML http://pharmtech.findpharma.com/pharmtech/Most+Viewed+Articles/Pfizer-accused-of-corporate-arrogance/ArticleStandard/Article/detail/637074?ref=25 A complaint submitted to the Federal Trade Commission has referred to Pfizer's acquisition of Wyeth as "potentially monopolistic" and has urged the Commission to see that "the proposed merger is not in the public interest and is in conflict with a wide range of President Obama's objectives". 2009-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637074null HTML http://pharmtech.findpharma.com/pharmtech/Generic-APIs-outstrip-innovation/ArticleStandard/Article/detail/637069?ref=25 The global API market has expanded from $69 billion in 2004 to more than $90 billion in 2008 at an average yearly growth rate of 7.2%, according to a report from the Italian Chemical Pharmaceutical Association (CPA). 2009-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637069null HTML http://pharmtech.findpharma.com/pharmtech/FDA-tracks-influenza-A-treatment-with-prescription/ArticleStandard/Article/detail/637072?ref=25 The FDA is using prescription data from Wolters Kluwer Pharma Solutions to track the treatment of influenza A (H1N1) and other influenza viruses. 2009-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637072null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Cargill-updates-industry-on-portfolio-innovations/ArticleStandard/Article/detail/637079?ref=25 Cargill has recently announced a number of innovations connected to its range of polyol excipients. 2009-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637079null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Residual-Solvents-Alternate-Validated-Methods/ArticleStandard/Article/detail/637714?ref=25 The USP General Chapter <467> on Residual Solvents became effective on July 1, 2008. Alternate methods may need to be developed and validated for compounds and any other unlisted solvents used in manufacturing that cannot be tested by the General Chapter's GC method. Lancaster Laboratories' analysts have been utilizing a technique referred to as a self-validating method. The benefit to this self-validating method approach includes a faster timeline and is more cost effective than the traditional approach for clients having a short term or infrequent need for testing. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637714null REMOTE http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-26-2009-OXiGENE-to-Acquire-VaxGen-Warn/ArticleStandard/Article/detail/637174?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/Residual-Solvents-Alternate-Validated-Methods---La/ArticleStandard/Article/detail/637563?ref=25 Residual Solvents: Alternate Validated Methods - Lancaster Whitepaper 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637563null PDF http://pharmtech.findpharma.com/pharmtech/News/GAO-Report-Calls-Out-FDAs-Poor-Oversight-of-Accele/ArticleStandard/Article/detail/637175?ref=25 The US Food and Drug Administration needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a September report from the Government Accountability Office (GAO) that was released this week. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637175null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Generic-APIs-Outstrip-Innovation/ArticleStandard/Article/detail/637179?ref=25 The global API market has expanded from $69 billion in 2004 to more than $90 billion in 2008, according to a report from the Italian Chemical Pharmaceutical Association (CPA); in particular, the report noted a rapid growth rate for generic APIs. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637179null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Rapid-Growth-of-Full-Time-Equivalent-Staffing-Prog/ArticleStandard/Article/detail/637729?ref=25 With the global economy in a recession, a vast majority of pharmaceutical companies are being forced to cut costs and control spending. For most companies this means a reduction in workforce and tighter outsourcing budgets. Companies are left with the same amount of required laboratory testing, but with fewer employees to perform the work in-house. Clients are left searching for value-added programs that will allow them to project all of their outsourcing costs for an entire year in order to lock in on set annual costs. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637729null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Tracks-Influenza-A-Treatment-with-Prescription/ArticleStandard/Article/detail/637177?ref=25 The US Food and Drug Administration is using prescription data from Wolters Kluwer Pharma Solutions to track the treatment of influenza A (H1N1) and other influenza viruses, according to a statement that the company released last week. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637177null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Authorizes-Emergency-Use-of/ArticleStandard/Article/detail/637172?ref=25 Also, FDA's DDMAC issues Warning Letter to King Pharmaceuticals; draft guidance released for SPL standards for content of labeling. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637172null HTML http://pharmtech.findpharma.com/pharmtech/Rapid-Growth-of-Full-Time-Equivalent-Staffing-Prog/ArticleStandard/Article/detail/637543?ref=25 Rapid Growth of Full Time Equivalent Staffing Programs - Lancaster Whitepaper 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637543null PDF http://pharmtech.findpharma.com/pharmtech/Ingredients/House-Committee-Passes-IST-Requirements-in-Chemica/ArticleStandard/Article/detail/637178?ref=25 The House Energy and Commerce Committee approved H.R. 2868, the "Chemical Facility Anti-Terrorism Act of 2009," a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards (CFATS) program. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637178null HTML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/Barcode-technology-addresses-the-counterfeit-dilem/ArticleStandard/Article/detail/637255?ref=25 New barcoding technologies are helping to aid product traceability and fight counterfeits. Mark Beauchamp of Citizen Systems Europe explains how. 2009-10-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637255/thumbnail_thumbnail.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637255null HTML http://pharmtech.findpharma.com/pharmtech/Product-profile/ArticleStandard/Article/detail/636757?ref=25 Acute intoxications require immediate reaction-based on reliable analysis. Shimadzu's TOX.I.S. system delivers fast results applying automated process as well as universal sample pre-treatment and identification methods 2009-10-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636757null HTML http://pharmtech.findpharma.com/pharmtech/Pharmaceutical-Technology-Podcast-Series-on-Supply/ArticleStandard/Article/detail/636866?ref=25 2009-10-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636866null HTML http://pharmtech.findpharma.com/pharmtech/Design-Space-Development-Design-for-Manufacturing-/ArticleStandard/Article/detail/636616?ref=25 Design Space Development, Design for Manufacturing and PAT - Aegis Whitepaper 2009-10-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636616null PDF http://pharmtech.findpharma.com/pharmtech/ERP-strategies-and-Best-Practices-for-Emerging-Lif/ArticleStandard/Article/detail/636536?ref=25 ERP strategies and Best Practices for Emerging Life Science Companies - Ross Whitepaper 2009-10-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636536null PDF http://pharmtech.findpharma.com/pharmtech/News/Generics-prevent-innovations-in-pharma/ArticleStandard/Article/detail/635260?ref=25 Cheaper generic pharmaceuticals, emboldened by US law and patent challenges, restrict novel future innovations. 2009-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635260null HTML http://pharmtech.findpharma.com/pharmtech/Counterfeit-medicines-more-profitable-than-heroin/ArticleStandard/Article/detail/635259?ref=25 The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about. 2009-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635259null HTML http://pharmtech.findpharma.com/pharmtech/FDA-new-guidance-on-drug-labeling-and-pharmacologi/ArticleStandard/Article/detail/635283?ref=25 The FDA issued a guidance for industry and review staff titled, 'Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information'. 2009-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635283null HTML http://pharmtech.findpharma.com/pharmtech/Pfizer-and-Wyeth-begin-operations-as-a-combined-co/ArticleStandard/Article/detail/635469?ref=25 Following the completion of its $68-billion acquisition of Wyeth, Pfizer has begun operations at the new combined company. 2009-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635469null HTML http://pharmtech.findpharma.com/pharmtech/Charged-Aerosol-Detection-in-Pharmaceutical-Analys/ArticleStandard/Article/detail/636147?ref=25 Charged Aerosol Detection in Pharmaceutical Analysis - Synomics Pharma Whitepaper 2009-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/636147null PDF http://pharmtech.findpharma.com/pharmtech/News/Uniting-all-CROs/ArticleStandard/Article/detail/635281?ref=25 US-based CRO, Health Decisions, hopes to raise the efficacy standards for complex studies and help companies get products to market faster by establishing an international network of CROs. 2009-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635281null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/EFCG-Counterfeit-Medicines-More-Profitable-than-He/ArticleStandard/Article/detail/635540?ref=25 The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about. 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635540null HTML http://pharmtech.findpharma.com/pharmtech/e-solution-broadcast/ArticleStandard/Article/detail/636004?ref=25 e-solution broadcast 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/636004null PDF http://pharmtech.findpharma.com/pharmtech/Pharm-Tech-custom-e-newsletter/ArticleStandard/Article/detail/635994?ref=25 PharmTech custom e-newsletter 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635994null PDF http://pharmtech.findpharma.com/pharmtech/Ingredients/Pfizer-and-Wyeth-Begin-Operations-as-a-Combined-Co/ArticleStandard/Article/detail/635536?ref=25 Following the completion of its $68-billion acquisition of Wyeth (Madison, NJ), Pfizer (New York) began joint operations of the combined company last week. 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635536null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Regulatory-Roundup-FDA-and-FTC-Issue-Joint-Warning/ArticleStandard/Article/detail/635530?ref=25 The two agencies issued a joint Warning Letter to the owners of a website selling unapproved products intended to treat the swine flu virus. 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635530null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Issues-New-Guidance-on-Drug-Labeling-and-Pharm/ArticleStandard/Article/detail/635534?ref=25 The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information. 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635534null HTML