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. 2008-10-06T21:39:43Z http://pharmtech.findpharma.com/pharmtech/Manufacturing/Lilly-to-Establish-Registry-of-its-Payments-to-Phy/ArticleStandard/Article/detail/555701?ref=25 Eli Lilly and Company plans to launch an online registry of its payments to physicians in 2009. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/555701null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-to-Cut-up-to-850-Jobs/ArticleStandard/Article/detail/555724?ref=25 Also, Alpharma advises shareholders to reject King's offer; ImClone rejects raised BMS offer; Immunogen appoints Daniel M. Junius, more... 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/555724null HTML http://pharmtech.findpharma.com/pharmtech/News/Pediatric-Drug-Rulemaking-Open-for-Public-Comment/ArticleStandard/Article/detail/555700?ref=25 A public meeting is being held today to discuss over-the-counter cough and cold medications for pediatric use. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/555700null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/WirelessHART-Gains-IEC-Approval/ArticleStandard/Article/detail/555698?ref=25 The International Electrotechnical Commission (IEC) has approved HART 7.1, the WirelessHART Communication Specification, as a Publicly Available Specification (IEC/PAS 62591Ed.1). WirelessHART is the first industrial wireless communication technology to achieve this level of approval. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/555698null HTML http://pharmtech.findpharma.com/pharmtech/Article/Contract-Manufacturers-and-Pharmaceutical-Ingredie/ArticleStandard/Article/detail/553579?ref=25 SAFC, Regis Technologies, Carbogen Amcis, Cambridge Major Laboratories, and AMRI are among the companies at CPhI Worldwide in Frankfurt this week that are moving forward with expansions. 2008-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/553579null HTML http://pharmtech.findpharma.com/pharmtech/Article/Ionic-Liquids-in-the-Chemical-Synthesis-of-Pharmae/ArticleStandard/Article/detail/552614?ref=25 Ionic liquids provide an alternative to certain solvents in select reactions used to synthesize intermediates and active pharmaceutical ingredients. 2008-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552614null HTML http://pharmtech.findpharma.com/pharmtech/PharmTech-media-kit---emailable-version/ArticleStandard/Article/detail/555831?ref=25 PharmTech media kit email version 2008-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/555831null PDF http://pharmtech.findpharma.com/pharmtech/2008-June-PBA-Statement/ArticleStandard/Article/detail/554311?ref=25 2008 June BPA Statement 2008-09-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/554311null PDF http://pharmtech.findpharma.com/pharmtech/2009-PharmTech-Media-Kit/ArticleStandard/Article/detail/554303?ref=25 2009 PharmTech Media Kit 2008-09-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/554303null PDF http://pharmtech.findpharma.com/pharmtech/2009-Editorial-Calendar/ArticleStandard/Article/detail/554316?ref=25 2009 Editorial Calendar 2008-09-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/554316null PDF http://pharmtech.findpharma.com/pharmtech/2009-e-media-kit/ArticleStandard/Article/detail/555155?ref=25 2009 e-Media kit 2008-09-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402008/555155null PDF http://pharmtech.findpharma.com/pharmtech/Manufacturing/House-Questions-FDAs-Priorities/ArticleStandard/Article/detail/552660?ref=25 In a Sept. 17 letter to FDA Commissioner Andrew C. von Eschenbach, Rep. Henry Waxman (D-CA) questions the agency's priorities, specifically poking at FDA's political appointees and whether they are promoting industry at the expense of the public's health. 2008-09-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552660null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Committee-on-Energy-and-C/ArticleStandard/Article/detail/552707?ref=25 Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more... 2008-09-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552707null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Outlines-Rules-on-Genetically-Engineered-Anima/ArticleStandard/Article/detail/552661?ref=25 In an effort to clarify its policy on the use and creation of genetically engineered animals (GE animals), the US Food and Drug Administration released the draft guidance "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs" on September 18. 2008-09-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552661null HTML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/Wyeth-Prepares-for-Supreme-Court-Preemption-Case/ArticleStandard/Article/detail/552662?ref=25 On November 3, the US Supreme Court will hear the case of Wyeth v. Levine, in which the drug company has challenged the ruling of a Vermont Supreme Court decision to award Diana Levine $6.8 million. 2008-09-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552662null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Study-Promotes-HatchndashWaxman-Model-for-Biologic/ArticleStandard/Article/detail/552658?ref=25 A new study concludes that an approval pathway for affordable follow-on biologics should be based on the Hatch–Waxman Act of 1984. 2008-09-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552658null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Nano-Ships-Designed-for-Drug-Delivery/ArticleStandard/Article/detail/550871?ref=25 Researchers from the University of California San Diego, UC  Santa Barbara, and MIT have developed nanometer-sized hybrid structures carrying anti-cancer drugs and quantum dot imaging agents. 2008-09-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550871null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/ImClone-Systems-Rejects-Bid-by-Bristol-Myers-Squib/ArticleStandard/Article/detail/550870?ref=25 The biopharmaceutical company ImClone Systems rejected Bristol-Myers Squibb's previously announced bid of $60 per share in cash or $4.5 billion for acquiring ImClone, citing the bid as "inadequate." 2008-09-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550870null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-King-Commences-Tender-Off/ArticleStandard/Article/detail/550918?ref=25 Also, Quintiles to expand Singapore operations; Christine A. Poon, chairman of Johnson & Johnson's pharmaceuticals group, to retire; more... 2008-09-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550918null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/MannKind-Will-Help-Patients-Switch-from-Exubera-to/ArticleStandard/Article/detail/550869?ref=25 MannKind and Pfizer (New York) agreed that the former company will help patients who need inhaled insulin switch from Pfizer's "Exubera" medicine to MannKind's "Technosphere Insulin" drug. 2008-09-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550869null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Issues-Warning-Letters-and-Import-Alert-on-Ran/ArticleStandard/Article/detail/550866?ref=25 The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories. 2008-09-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550866null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Preparation-for-ICH-Brussels-Begins/ArticleStandard/Article/detail/550872?ref=25 In November, representatives to the International Conference on Harmonization will meet in Brussels, Belgium, to discuss several international cooperation initiatives, including ICH Q10: Pharmaceutical Quality System and ICH Q8R: Pharmaceutical Development. 2008-09-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550872null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Quarterly-Reports-Notify-Public-of-Potential-Safet/ArticleStandard/Article/detail/550867?ref=25 Earlier this month, the US Food and Drug Administration announced that it will be posting quarterly reports on its website regarding potential drug safety issues. 2008-09-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550867null HTML http://pharmtech.findpharma.com/pharmtech/Qualification-Pitfalls-and-How-to-Avoid-Them/ArticleStandard/Article/detail/550458?ref=25 Qualification demonstrates that equipment is what it is purported to be and does what it is supposed to do. Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) are the three steps of equipment qualification. 2008-09-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550458null HTML http://pharmtech.findpharma.com/pharmtech/September-2008-Editors-Picks-Products-from-LiquaJe/ArticleStandard/Article/detail/550121?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the September 2008 edition from LiquaJet and Yokogawa. 2008-09-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550121null HTML http://pharmtech.findpharma.com/pharmtech/Dispensing-Biopharmaceuticals-with-Piston-and-Peri/ArticleStandard/Article/detail/550135?ref=25 Piston pumps have been a traditional liquid-filling technology for biopharmaceutical manufacturers, but new challenges, stricter validation requirements, and design innovations have led manufacturers to consider peristaltic filling technology. 2008-09-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550135null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/The-US-FDA-Orphan-Drug-Product-Program/ArticleStandard/Article/detail/550661?ref=25 The Orphan Drug White Paper provides a description of the history and content of the Orphan Drug Act including various statistics through 2005. The paper also describes the orphan drug designation and orphan drug grant processes in sufficient detail for applicants to be able to file an orphan drug designation or grant request. 2008-09-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550661null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Takes-First-Step-in-Modernizing-CGMPs/ArticleStandard/Article/detail/548934?ref=25 FDA has issued a Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals." 2008-09-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548934null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/CEFIC-Forms-REACH-Service/ArticleStandard/Article/detail/548937?ref=25 The European Chemical Industry Council and five national chemical associations representing France, Germany, Italy, Spain, and the United Kingdom, have launched ReachLink. ReachLink is a company founded to help companies participate in the Substance Information Exchange Forum (SIEF), which is designed as an information-sharing vehicle to facilitate companies in meeting requirements under REACH 2008-09-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548937null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/New-FDA-Website-Provides-Information-about-DTC-Ads/ArticleStandard/Article/detail/548938?ref=25 The US Food and Drug Administration launched a new website to educate the general public about direct-to-consumer (DTC) advertising of prescription medications. 2008-09-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548938null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-FTC-Asks-Teva-and-Barr-Fo/ArticleStandard/Article/detail/549003?ref=25 Also, Human Genome Sciences enters pact with Hospira, Zosano Pharma names Gail Schulze chair and CEO, more... 2008-09-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549003null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Updates-Bioequivalence-Guidelines/ArticleStandard/Article/detail/548936?ref=25 The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007. 2008-09-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548936null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Color-vs-Appearance-Choose-the-appropriate-instrum/ArticleStandard/Article/detail/548039?ref=25 With the number of color measuring instruments on the market, how do you choose the most appropriate one? It helps to understand the difference between measuring color and measuring appearance. 2008-09-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/548039null REMOTE http://pharmtech.findpharma.com/pharmtech/Outsourcing/Global-Biochemical-Profiling-for-Bioprocessing-Opt/ArticleStandard/Article/detail/548038?ref=25 It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical. Organizations must analyze everything from total protein production level to glycosylation patterns as well as overall quality and stability. Given the large numbers of variables involved—especially in the composition of media nutrients—it is has been difficult to achieve globally optimal conditions using traditional analysis methods. This paper provides an overview of the type of relevant information that global biochemical profiling (metabolomics) can provide. Through this global analysis, one can not only measure these changes but also put them into biological context and—most importantly—into application. 2008-09-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/548038null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/Solid-Dose-Calibrator-for-Karl-Fischer-Titration/ArticleStandard/Article/detail/547783?ref=25 This article discusses the advantages of using a tablet as a standard for Karl Fischer titrations, and compares the results obtained using a tablet standard with those from two other commercial standards based on other delivery systems. 2008-09-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/547783null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/Managing-the-Regulatory-Submission-Project/ArticleStandard/Article/detail/547784?ref=25 Preparing a regulatory submission document can be costly in regards to resources and time. It is important to follow project management principles to ensure a cost effective and successful submission. This paper provides a summary of the overall process for managing a regulatory submission project. 2008-09-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/547784null REMOTE http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-and-Valeant-Collabora/ArticleStandard/Article/detail/547486?ref=25 Also, Novartis stops development on "Aurograb," Zealand Pharma appoints David H. Solomon as CEO, more... 2008-09-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/547486null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/NAS-Launches-and-NME-Approvals-Declined-in-2007/ArticleStandard/Article/detail/547457?ref=25 Companies launched 25 new active substances in 2007, a decline of 19% from the previous year, according to a new report from Parexel International. 2008-09-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/547457null HTML http://pharmtech.findpharma.com/pharmtech/Testing/USP-Revises-Potency-Spec-for-Levothyroxine-Sodium-/ArticleStandard/Article/detail/547455?ref=25 USP announced an interim revision to its monograph for levothyroxine sodium tablets, which will become official in USP 32-NF 27. 2008-09-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/547455null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Boehringer-Ingelheim-Partners-with-Chinese-Interme/ArticleStandard/Article/detail/547456?ref=25 Boehringer Ingelheim and and Hisoar (Taizhou, China), a pharmaceutical production company, formed a strategic production alliance in China. 2008-09-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362008/547456null HTML http://pharmtech.findpharma.com/pharmtech/Setting-a-Regulatory-Framework-for-Nanotechnology/ArticleStandard/Article/detail/544940?ref=25 The US Food and Drug Administration will hold a public meeting this month to gain public input on implementing the recommendations of the Nanotechnology Task Force report, taking another step closer to setting a regulatory framework for nanotechnology for pharmaceuticals and medical devices. 2008-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/544940null HTML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Clinical-Outsourcing-Steams-Ahead/ArticleStandard/Article/detail/544941?ref=25 CMC service providers are doing well, but clinical and preclinical CROs are doing even better. 2008-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/544941null XML http://pharmtech.findpharma.com/pharmtech/Advances-in-Green-Chemistry-for-Pharmaceutical-App/ArticleStandard/Article/detail/544937?ref=25 The pharmaceutical majors deploy green-chemistry strategies to improve the synthesis of active pharmaceutical ingredients and intermediates. 2008-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/544937null HTML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Continuous-Processing-Moving-with-or-against-the-M/ArticleStandard/Article/detail/549164?ref=25 Fueled by a need to reduce costs and improve efficiencies, continuous processing may be the next paradigm shift in pharmaceutical manufacturing. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549164/sept_52_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Testing+Article/Running-a-Marathon-in-Flip-Flops-ndash-Part-2-The-/ArticleStandard/Article/detail/550367?ref=25 Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550367/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550367null XML http://pharmtech.findpharma.com/pharmtech/IT/Pharma-Capsules/ArticleStandard/Article/detail/549171?ref=25 Brief pharmaceutical news items for September 2008. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549171null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Drug-Imports-under-Scrutiny/ArticleStandard/Article/detail/549162?ref=25 FDA is taking several measures to ensure that imported drugs meet manufacturing standards. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549162null XML http://pharmtech.findpharma.com/pharmtech/Article/The-Potential-of-Continuous-Sterile-Manufacturing/ArticleStandard/Article/detail/550369?ref=25 Sterile manufacturing may be the next aspect of pharmaceutical manufacturing to consider in the continuous process paradigm. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550369/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550369null XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Hits-and-Strikes/ArticleStandard/Article/detail/549160?ref=25 Operators are hit hard by breakage problems and strike out on FDA inspections. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549160null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/A-Catalyst-for-Environmental-Consciousness/ArticleStandard/Article/detail/550366?ref=25 A recent book shows the links between synthesis, catalysis, and environmental protection. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550366/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550366null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Big-Deals/ArticleStandard/Article/detail/549167?ref=25 Summer deals struck by Novartis and Lilly point to an evolution in contract services. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549167null XML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling+Article/Sustainability-Surprises/ArticleStandard/Article/detail/549163?ref=25 Identifying the most sustainable packaging for a product is rarely a simple exercise. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549163null XML http://pharmtech.findpharma.com/pharmtech/IT/Dirty-Hands/ArticleStandard/Article/detail/549158?ref=25 Are hypersanitation trends a result of scaremongering or a lack of faith in medicine? 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549158null XML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling+Article/Criticality-Management-of-a-Drug-Product-and-its-M/ArticleStandard/Article/detail/549165?ref=25 Criticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549165null XML http://pharmtech.findpharma.com/pharmtech/IT/Make-Yourself-Count/ArticleStandard/Article/detail/549159?ref=25 This year, the employment survey will acknowledge the industry's best employers. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549159null XML http://pharmtech.findpharma.com/pharmtech/Article/Chiral-Separations/ArticleStandard/Article/detail/550368?ref=25 The selection of the chiral stationary phase is an important consideration in separating enantiomers when using high-performance liquid chromatography, supercritical fluid chromatography, and simulated moving bed chromatography. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550368/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382008/550368null XML http://pharmtech.findpharma.com/pharmtech/Article/Dielectric-Spectroscopy-Choosing-the-Right-Approac/ArticleStandard/Article/detail/549166?ref=25 This tutorial paper is meant to aid in dielectric-sensor selection 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549166/sept_82_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549166/sept_82_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Achieving-Enantioselectivity/ArticleStandard/Article/detail/549170?ref=25 Carbon–hydrogen functionalization, ketone α-alkylation, and biocatalysis are some recent advances in asymmetric synthesis. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549170/sept_60_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Global-Warming-Heats-Up-Need-for-Malaria-Vaccine/ArticleStandard/Article/detail/549168?ref=25 With economics and politics in the way, can we defeat the malaria epidemic before it defeats us? 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549168null XML http://pharmtech.findpharma.com/pharmtech/IT/In-the-Spotlight/ArticleStandard/Article/detail/549161?ref=25 Editors' Picks of Pharmaceutical Science & Technology Innovations 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549161null XML http://pharmtech.findpharma.com/pharmtech/Article/Report-From-India/ArticleStandard/Article/detail/549536?ref=25 Differential pricing is making more than just an appearance in Asia's pharma market these days. 2008-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/549536null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Industrial-Applications-of-Whole-Cell-Biocatalysis/ArticleStandard/Article/detail/548828?ref=25 Recombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases. 2008-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548828null XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Highly-Efficient-Olefin-Metathesis-Catalysts/ArticleStandard/Article/detail/548825?ref=25 The authors describe the Piers' catalysts and detail latest progress in olefin-metathesis catalyst technology. 2008-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548825null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Manufacturing-Considerations-for-Sourcing-GMP-Ferm/ArticleStandard/Article/detail/548826?ref=25 The authors describe the critical aspects of an ideal fermentation services provider. 2008-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548826null XML http://pharmtech.findpharma.com/pharmtech/Article/Power-Ultrasound-and-the-Production-of-Mesoscopic-/ArticleStandard/Article/detail/548822?ref=25 The authors discuss advanced sonocrystallization particle-engineering techniques for manufacturing mesoscopic particles. 2008-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548822null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/High-Potency-APIs-Containment-and-Handling-Issues/ArticleStandard/Article/detail/548824?ref=25 The author explains the planning, equipment, and facility design requried for manufacturing HPAPIs and specialized requirements for handling these compounds. 2008-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548824null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Epedigree-in-the-Pharmaceutical-Supply-Chain/ArticleStandard/Article/detail/548823?ref=25 EPedigree, track-and-trace technologies, and other tools for optimizing supply-chain management are of increasing importance to the pharmaceutical industry. The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients. 2008-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548823null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Expansion-Activity-of-CMOs/ArticleStandard/Article/detail/548827?ref=25 The outlook is fairly optimistic as contract manufacturing organizations (CMOs) gather at CPhI Worldwide in Frankfurt. CMOs are expanding capacity for small-molecules, biologics, and finished-product manufacturing. 2008-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372008/548827null XML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Economic-Impact-Increases-but-Employment-Falls-for/ArticleStandard/Article/detail/545161?ref=25 The Healthcare Institute of New Jersey (HINJ) released a new research study showing that New Jersey's life-science industry experienced stable growth in 2007. 2008-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/545161null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/King-Pharmaceuticals-Bids-14-Billion-for-Alpharma/ArticleStandard/Article/detail/545160?ref=25 The specialty drug company King Pharmaceuticals is seeking to acquire the specialty pharmaceutical company Alpharma (Bridgewater, NJ) through an unsolicited bid of $33 per share or $1.4 billion in cash. Alpharma has rejected the bid. 2008-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/545160null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Time-is-Running-out-for-Innovation-Awards/ArticleStandard/Article/detail/545141?ref=25 The deadline for nominations for the Innovations in Pharma Science Awards is here. Check out http://pharmtech.com/Innovations to nominate your company's work in one of five areas by next week 2008-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/545141null HTML http://pharmtech.findpharma.com/pharmtech/News/Public-Comment-on-Cough-and-Cold-Meds-for-Kids/ArticleStandard/Article/detail/545159?ref=25 The US Food and Drug Administration will hold a public hearing Oct. 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. 2008-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/545159null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/FDA-Finalizes-Labeling-Changes-Rule/ArticleStandard/Article/detail/545146?ref=25 FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval applicatin (PMA). 2008-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/545146null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Company-and-People-Notes-Gilead-Sciences-to-Expand/ArticleStandard/Article/detail/545230?ref=25 Also, Shire recalls "Daytrana" patch, Chromatide forms Scientific Advisory Board, more... 2008-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352008/545230null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-CSL-to-Acquire-Talecris-B/ArticleStandard/Article/detail/543542?ref=25 Also, Tekmira will collaborate with Bristol-Myers Squibb, Helicos Biosciences appoints Steve Lombardi CEO, more... 2008-08-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342008/543542null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Misuse-of-Narcotics-May-Call-for-Additional-Doctor/ArticleStandard/Article/detail/543483?ref=25 The US Food and Drug Administration may soon ask doctors to undergo special training to be able to prescribe powerful narcotics, Dr. Bob Rappaport told The New York Times last week. Rappaport, director of FDA's Anesthesia, Analgesia and Rheumatology Products division, said the agency is considering recommending additional education for doctors in early 2009. 2008-08-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342008/543483null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/SOCMA-Expresses-Trade-Concerns-with-REACH-Implemen/ArticleStandard/Article/detail/543486?ref=25 The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use. 2008-08-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342008/543486null HTML http://pharmtech.findpharma.com/pharmtech/Testing/USP-Opens-Site-in-Brazil/ArticleStandard/Article/detail/543484?ref=25 The US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil. 2008-08-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342008/543484null HTML http://pharmtech.findpharma.com/pharmtech/Article/August-2008-Editors-Picks-Products-from-OYSTAR-Man/ArticleStandard/Article/detail/542946?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the August 2008 edition from OYSTAR Manesty and Hawk. 2008-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342008/542946null HTML http://pharmtech.findpharma.com/pharmtech/Article/After-Formaldehyde-Comparing-Alternative-Decontami/ArticleStandard/Article/detail/542595?ref=25 Decontaminating pharmaceutical manufacturing facilities is essential for producing safe and pure drugs. The most commonly used decontaminant in the industry has been sublimated formaldehyde. 2008-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332008/542595null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/How-to-Be-Green-in-a-CGMP-Regulated-Environment/ArticleStandard/Article/detail/542939?ref=25 The concept of the the triple bottom line incorporates a company's financial, social, and environmental performance. As a result, an increasing number of companies are investigating how sustainable, green technologies and practices can help them stay competitive in a challenging regulated market. 2008-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342008/542939null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Seeks-Contractors-for-Sentinel-System/ArticleStandard/Article/detail/542060?ref=25 The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency's Sentinel Initiative. 2008-08-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332008/542060null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Actavis-Voluntary-Recalls-Products-for-GMP-Violati/ArticleStandard/Article/detail/542065?ref=25 Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year. 2008-08-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332008/542065null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Genentech-Rejects-Roches-/ArticleStandard/Article/detail/542276?ref=25 Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more... 2008-08-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332008/542276null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Releases-Draft-Guidance-on-Residual-Solvents/ArticleStandard/Article/detail/542062?ref=25 The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment. 2008-08-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332008/542062null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Sterile-Manufacturing-Draft-Guidance-Provides-Appl/ArticleStandard/Article/detail/542067?ref=25 The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing. 2008-08-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332008/542067null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Magnetic-Mixers-How-Are-They-Different/ArticleStandard/Article/detail/535012?ref=25 Magnetic mixers are known to offer significant processing advantages over other types of mixers. This white paper touches on those differences, but focuses heavily on the differences between the different magnetic mixer designs. It highlights some of the most common issues with magnetic mixing, and how one mixer has overcome these issues. 2008-08-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332008/535012null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/BMS-Bids-45-Billion-for-ImClone-Systems/ArticleStandard/Article/detail/534324?ref=25 Bristol-Myers Squibb is seeking to acquire the biopharmaceutical company ImClone Systems (New York) for $4.5 billion or $60 per share. BMS currently holds a 17% stake in ImClone. 2008-08-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534324null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Meda-will-Acquire-Valeant/ArticleStandard/Article/detail/534390?ref=25 Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more... 2008-08-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534390null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Revised-Discussion-Draft-of-FDA-Globalization-Act-/ArticleStandard/Article/detail/534325?ref=25 The House Committee on Energy and Commerce issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008. 2008-08-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534325null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Fire-rated-pallets-What-you-need-to-know/ArticleStandard/Article/detail/534538?ref=25 This paper attempts to identify some of the specifics of the process used to obtain approval for use of plastic pallets as equivalent to wood pallets for use in warehouse storage. This paper is written to look at the issue in general and is not intended to cover all storage situations. Your specific situation should be evaluated by a fire protection specialist. 2008-08-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534538null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDAs-Complete-Responses-Commence/ArticleStandard/Article/detail/534316?ref=25 Next week, the US Food and Drug Administration's communications with pharmaceutical companies will change, and the agency will begin issuing complete response letters in place of approvable letters. 2008-08-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534316null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/User-Fee-Rates-for-FY-2009-Announced/ArticleStandard/Article/detail/534323?ref=25 The US Food and Drug Administration released its user fee rates for fiscal year 2009 last Friday. 2008-08-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534323null HTML http://pharmtech.findpharma.com/pharmtech/Fundamentals-Are-Strong-for-Global-CRO-Market/ArticleStandard/Article/detail/533225?ref=25 Strong profitability and good growth prospects bode well for the global market for contract research organizations. 2008-08-06T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312008/533225null HTML http://pharmtech.findpharma.com/pharmtech/Outsourcing-Practices-Scrutinized-by-Congress/ArticleStandard/Article/detail/533228?ref=25 The pharmaceutical industry?s outsourcing practices receive increased attention as Congress evaluates the role of outsourcing in drug-safety issues. 2008-08-06T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312008/533228null HTML http://pharmtech.findpharma.com/pharmtech/Article/Help-Your-Contract-Laboratory-Help-You/ArticleStandard/Article/detail/533290?ref=25 Providing the right information upfront may ease new requirements to assess solvent levels. 2008-08-06T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312008/533290null XML http://pharmtech.findpharma.com/pharmtech/IT/Saved-by-the-Delay/ArticleStandard/Article/detail/534710?ref=25 Postponement of California's deadline gives the supply chain time to refine ePedigree solutions. 2008-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534710null XML http://pharmtech.findpharma.com/pharmtech/IT/FDA-and-Medicare-at-Odds/ArticleStandard/Article/detail/534698?ref=25 Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals. 2008-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534698null XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Suspicious-Times/ArticleStandard/Article/detail/534700?ref=25 Agents report unusual chemistry, abnormal data analysis, and unconventional work practices. 2008-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534700null XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Charting-Advances-at-CRS/ArticleStandard/Article/detail/534699?ref=25 This year's meeting of the Controlled Release Society unveiled a plethora of research insights. 2008-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322008/534699null XML