Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery.

Formulation Development Forum: Nanosized Dendrimers

The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.

FDA Perspectives: Designation of Regulatory Starting Materials in the Manufacturing of Drug Substances: Impact on ANDA Review Time

Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.

Contract API Manufacturing: The Year in Review

The seventh in a series of eight case studies from the Product Quality Research Institute focuses on packout remedies.

PQRI Case Study (7): PackOut Remedies to Minimize Contamination and Exposure

Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.

Views from Pharma Leaders: A Year in Review and a Look Forward

The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.

The Development of a Floating Drug-Delivery System for Metronidazole

Amy Ritter was Scientific Editor, BioPharm International.

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

The Employment Outlook Brightens

The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits.

PQRI Case Study (8): Internal GMP Audit Program

The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.

PQRI Case Study (6): Packaging Line GMP Optimization

Researchers develop various catalytic approaches for improving yield, purity, stereoselectivity, and process conditions.

Ingredients