Using Analytical Techniques to Examine Tablet Sticking
Analytical tests, correlated with statistical techniques, are used to predict material behavior.

Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
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).

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Establishing a Minimum Incubation Time for Biological Indicators
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.

Q&A with Brian Galliher, Cook Pharmica
Brian Galliher of Cook Pharmica discusses visual inspection systems.

Ron Piervincenzi Named Next CEO of USP
Ron Piervincenzi to assume leadership of the United States Pharmacopeial Convention on Feb. 1, 2014.

EMA Adds Statements of GMP Non-Compliance to EudraGMDP
EMA has launched a new version of the EudraGMDP database, which includes the publication of statements of non-compliance with good manufacturing practice.

Most-Read News Stories of 2013
While the Affordable Care Act, Pope Francis, and the government shutdown were top general news stories in 2013, the bio/pharmaceutical industry had its own headlines.

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GE Acquires Cell Culture Media and Sera Assets from Thermo Fisher Scientific
GE acquires Thermo Fisher-s HyClone cell culture media and sera products, gene modulation technologies, and magnetic beads businesses.

FDA Announces Voluntary Recall from Abrams Royal Compounding Pharmacy
Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US.

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Animal Vaccine Study May Advance HIV Vaccine Research
A monkey-vaccine study provides insight into HIV research.

Testosterone-Regulated Genes May Affect Vaccine Immunity
A study led by Stanford University explains why men may have weaker responses to vaccines than women.

Mac Process and Schenck AccuRate To Merge and Be Renamed
Mac Process will merge with Schenck AccuRate and combine their operations under the name of Schenck Process.