Drug Development

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Articles

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?

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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.

FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 2: Description, Composition, and Excipients

Chemocatalytic and biocatalytic approaches in asymmetric synthesis help provide a pathway for producing single-enantiomer drugs.

Exploring Chiral Chemistry

Green chemistry in pharmaceutical development often centers around approaches in the synthesis of the active ingredient, but green-chemistry techniques also can be applied to drug-product manufacturing, formulation development, and drug delivery.

Green Drug Delivery: Spray-dried solid amorphous dispersions with a cellulosic exicpient

Duke University researchers have found a possible alternative to lyophilization.

APIs and Excipients