Analytics

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Orally disintegrating tablets (ODTs) continue to attract attention as an alternative to conventional oral dosage forms.

Advancing ODT Technology

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More.

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More

Double-digit growth is projected for the US generic drug market, and the industry positions for opportunities in biosimilars.

Opportunities Abound for Generic Drugs

Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.

EGA Raises Concerns Over Regulatory Workload in Approving Generics

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

FDA Releases Draft Guidance for Cell-Based Vaccine Development

I recently embarked on a quest: to investigate industry's use of the words, "generic" and "biosimilar" when describing a biologic molecule. An English major at heart, I was wrapped up in a news story that was partly about science, partly about words.

Uncertain Terms

Chemical purity is the most important quality characteristic of a pharmaceutical substance. This article describes the latest scientific and technological advances to meet recent pharmacopoeial and regulatory requirements regarding the control of organic impurities in synthetically produced active substances. Future developments and suggestions for those working in quality control and raw material selection are discussed.

Drug Substance Analysis