Drug Development

Ranga Velagaleti is the manager of laboratory and stability at BASF Corporation, 8800 Line Ave., Shreveport, LA 71106, tel. 318.861.8040, fax 318.861.8004, velagar1@basf-corp.com

Articles

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.

Solutol HS15 as a Novel Excipient

Stuart Needleman, president of active-ingredient development and manufacturing at Aptuit, discusses industry trends and challenges.

Q&A with Stuart Needleman, Aptuit

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

A recently released industry guide outlines a science- and risk-based approach to control the risk of cross-contamination.

Risk Mitigation in High-Potency Manufacturing

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Drugmakers hatch new manufacturing paradigms in the wake of the 2009 H1N1 influenza pandemic.

Vaccine Manufacturing Reborn

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

Process Analytical Technology-Based In-Line Buffer Dilution In Downstream Bioprocessing

The author describes the development of small-angle X-ray scattering and analyzes its advantages in the characterization of drug-delivery systems and large molecules. This article is part of a special Analytical Technology issue.

Small-Angle X-ray Scattering for Pharmaceutical Applications

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

How Can We Improve Dissolution Testing for Transdermals?

Pharmaceutical Technology gains insight into approaches for producing aromatic amines.

Technical Forum: Small-Molecule Synthesis

The author explains the background behind the excipient pedigree and how to implement its use.

Excipient Pedigree Verification

FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

APIs and Excipients