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Pharmaceutical Technology-12-02-2013
Pharmaceutical Technology
Rail-Mounted Fluid Bed Dryers Allow Cleaning Access
December 02, 2013
Product Spotlight
37
12
Rail-Mounted Fluid Bed Dryers Allow Cleaning Access
Biotechnology Innovation and Growth in Israel
December 02, 2013
Global Feature
37
12
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
Drug Manufacturing Focus: Why India?
December 02, 2013
Ask the Expert
37
12
Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
December 02, 2013
Regulation & Compliance
37
12
The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).
Clinical Trials Head East to Asia
December 02, 2013
Global Feature
37
12
The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.
Climate Change in Outsourcing
December 02, 2013
Outsourcing Outlook
37
12
Ongoing changes create new opportunities for CROs and CMOs.
Deficiencies Found in API Inspections
December 02, 2013
Regulation & Compliance
37
12
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
Q&A with Brian Galliher, Cook Pharmica
December 02, 2013
Industry Leaders: Q&A
37
12
Brian Galliher of Cook Pharmica discusses visual inspection systems.
Inspiring the Next Generation
December 02, 2013
Guest Editorial
37
12
Scientists can share time and pharmaceutical knowledge with high school students.
Establishing a Minimum Incubation Time for Biological Indicators
December 02, 2013
Peer-Reviewed
37
12
The industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
Implementing QbD in Sterile Manufacturing
December 02, 2013
Cover Story
37
12
Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.
Opioid Regulation Challenges FDA and Manufacturers
December 02, 2013
Regulatory Watch
37
12
New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
Low Feed Rate Feeder Designed for Pharmaceutical Processes
December 02, 2013
Product Spotlight
37
12
Low Feed Rate Feeder Designed for Pharmaceutical Processes
Tablet Tooling Coating Reduces Formulation Sticking
December 02, 2013
Product Spotlight
37
12
Tablet Tooling Coating Reduces Formulation Sticking
Industry Optimism Outweighs Personal Job Security
December 02, 2013
Special Report
37
12
Pharmaceutical Technology's 2013 Employment Survey reveals some optimism for the industry's future performance, but ongoing concerns about individual job prospects.
Uncertainty in the Workplace in Europe
December 02, 2013
Special Report
37
12
Industry mergers, acquisitions and downsizing contribute to uncertainty in job security in the European bio/pharmaceutical market.
Tracking Innovation in New Molecular Entities of 2013
December 02, 2013
API Synthesis & Manufacturing
37
12
A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.
Using Analytical Techniques to Examine Tablet Sticking
December 02, 2013
Troubleshooting
37
12
Analytical tests, correlated with statistical techniques, are used to predict material behavior.
Bioreactor Functions as Perfusion Mimic
December 02, 2013
Product Spotlight
37
12
Bioreactor Functions as Perfusion Mimic
Pharmaceutical Technology, December 2013 Issue (PDF)
December 02, 2013
Issue PDF
37
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Click the title above to open the Pharmaceutical Technology December 2013 issue in an interactive PDF format.