Recently added articles from Pharmaceutical Technology:
Correction
Jun 01, 2008; Anonymous ... In the April 2008 issue's Packaging Forum column, page 46, Filamatic's sanitary benchtop ...
Public Service Versus Self-Serving
Jun 01, 2008; Hoffman, Michelle ... The good, the bad, and the ugly about direct-to-consumer advertising. I was hanging out with a friend this weekend, when we got on the subject of drug advertisements on TV. My friend started imitating the way people are pictured in those ads frolicking through a beautiful garden or ...
PDA Takes On Risk for Patients
Jun 01, 2008; Rios, Maribel ... Risk management, and its benefits for patients, plays a big role at the PDA Annual Meeting. The 2008 PDA Annual Meeting in Colorado Springs was a good example of how the organization has grown. As Ted Meltzer, a long-time friend and renowned professional, told me: "The PDA organization ...
The Use of Complaining
Jun 01, 2008; Anonymous ... Control Customers complaining lead to some serious explaining. A precipitated inspection "Back in the days when FDA sometimes followed up on complaints by sending out the local inspector, we received an inspection following a complaint about a suspension product we ...
INTERACT in JUNE....
Jun 01, 2008; Anonymous ... * Worth reading Preformulation in Solid Dosage Form Development (InformaHealthcare, 2008) Eds. Moji Christianah Adeyeye, Harry Britain This new 596-page book discusses principles for the characterization of new drug compounds and substances during preformulation through Phase I ...
Report from: India
Jun 01, 2008; Nair, A ... With rising drug development costs and burdensome clinical trials, Indian-based firms are transferring their research departments to other entitites in hopes of saving cash, mitigating risk, and ultimately, buying back the rewards. Bangalore-based biotech firm Biocon is the new kid on ...
Postmarketing flops
Jun 01, 2008; Anonymous ... According to FDA data published in the Federal Register in late April, pharmaceutical companies' aren't keeping up with their postmarketing study commitments for new drug applications, abbreviated drug applications, and ...
COMING DOWN THE PIKE...
Jun 01, 2008; Hoffman, Michelle ... Anyone who lived through the '60s and remembers it undoubtedly had some experience-direct or otherwise-of tetrahydrocannabinol, the active ingredient in marijuana. The drug produces what many consider to be pleasant effects on the nervous system, the likely reason for its popularity. And that ...
World Briefs
Jun 01, 2008; Anonymous ... ASIA & PACIFIC Dr. Reddy's Laboratories (Hyderabad, India) completed two acquisitions: The Dow Chemical Company's Dowpharma small molecules business associated with its Mirfield and Cambridge, United Kingdom, sites, as well as BASF's manufacturing facility in Shreveport, Louisiana, ...
WHERE IS THAT?
Jun 01, 2008; Anonymous ... *Hyon, the third largest city in France, is located in the eastern central part of the country between Paris and Marseille. It is also centered between two rivers, the Rhône ...
Market Watch: DRUG DEVELOPMENT
Jun 01, 2008; Van Arnum, Patricia ... A recent survey conducted by Bearing Point and AMR Research found that 26% of more than 100 pharmaceutical and biotech executives surveyed expect to conduct 21 or more Phase I studies per year by 2010, an 18% increase from 2007. The survey also revealed significant growth in global trials, with ...
Zone in on: IT Wireless Automation Industry Inches Toward Convergence Document
Jun 01, 2008; Rios, Maribel ... Industry automation experts are keeping an eye on the developments in establishing a wireless standard document that seeks to take the best of WirelessHART and the best of ISA 100.11 a and combine them into one "convergence document." The convergence document would take the place of both so that ...
Trends in: Direct-to-Consumer Ads
Jun 01, 2008; Drakulich, Angie ... According to a new report from the Government Accountability Office (GAO), the US Food and Drug Administration is issuing fewer warning letters to companies regarding direct-to-consumer (DTC) advertising violations each year. Between 1997 and 2001, the agency issued 15-25 letters per year. In ...
Healthcare Reform Proposals Challenge Manufacturers
Jun 01, 2008; Wechsler, Jill ... Comparative-effectiveness analysis aims to promote appropriate pharmaceutical spending. As the presidential election campaign moves toward its final stage, Healthcare reform remains a highprofile issue. Efforts to expand coverage for the uninsured include proposals to curb outlays for ...
Editors' Picks of Pharmaceutical Science & Technology Innovations
Jun 01, 2008; Anonymous ... The pharmaceutical manufacturing line transforms research into reality, but it takes the right kind of equipment and technology to turn ingredients into dosage forms. With recent advances in material-handling equipment and automation devices, laboratory and manufacturing technicians can be more ...
Cell Manufacturing on a Large Scale
Jun 01, 2008; Hoffman, Michelle ... Creating a kinder; gentler manufacturing process that doesn't kill the product is the goal of process developers doing large-scale cell culture for cell therapy. This story is about a technology so new, it hasn't been invented yet. Not quite. It's so new that "Googling" the search term ...
Small Wonder: Nanoparticle Strategies for Biological Drugs
Jun 01, 2008; Greb, Erik ... Nanoparticle-based systems present many advantages for the delivery of current and emerging biological drugs. Anyone keeping abreast of industry trends in the pharmaceutical market has noticed the enthusiasm that drug developers, investors, and even traditional pharmaceutical companies ...
Antibody Drug Conjugates: A Marriage of Biologics and Small Molecules
Jun 01, 2008; Van Arnum, Patricia ... Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing. Targeted therapies such as monocolonal antibodies are an important part of anticancer drug development. Humanized antibodies may be used either alone in unlabeled or naked form or ...
Biopharmaceutical Manufacturing: The Challenge of Global Regulatory Compliance
Jun 01, 2008; Davis, Kelly ... This article provides an overview of key regulatory issues facing companies that seek to market their biopharmaceutical agents globally, including a trend toward harmonization of requirements as well as the remaining differences in rules concerning applications, good manufacturing practices ...
Variability of USP Lot P Prednisone Reference Standard Tablets
Jun 01, 2008; Hauck, Walter W; Deng, Gang; Glasgow, Maria J; Liddell, Mark R; Nithyanandan, Pallavi; Williams, Roger L ... Acceptance criteria for prednisone tablets have been criticized for several years as being too wide, based specifically on the USP Prednisone Reference Standard Tablets. In response, USP has conducted research on the performance of its Prednisone RS Tablets and dissolution procedure. The authors ...