Pharmaceutical Technology-12-02-2013

Rail-Mounted Fluid Bed Dryers Allow Cleaning Access

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.

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.

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).

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.

Ongoing changes create new opportunities for CROs and CMOs.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Brian Galliher of Cook Pharmica discusses visual inspection systems.

Scientists can share time and pharmaceutical knowledge with high school students.

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.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Low Feed Rate Feeder Designed for Pharmaceutical Processes

Tablet Tooling Coating Reduces Formulation Sticking

Pharmaceutical Technology's 2013 Employment Survey reveals some optimism for the industry's future performance, but ongoing concerns about individual job prospects.

Industry mergers, acquisitions and downsizing contribute to uncertainty in job security in the European bio/pharmaceutical market.

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

Bioreactor Functions as Perfusion Mimic

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