Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

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

Catalyzing the Synthesis

The study evaluates near-infrared analysis of tablets nominally containing 4 mg of chlorpheniramine maleate and 10 mg of phenylephrine hydrochloride per dose.

Near Infrared Analysis of Tablets Containing Two Active Ingredients

The authors describe the operational qualification of test accuracy with regard to temperature drift using a thermal-compensation algorithm on several freeze dryers.

Water-Intrusion Test Integration

The fifth in a series of eight case studies from the Product Quality Research Institute focuses on nonsterile facility cleaning requirements.

PQRI Case Study (5): Nonsterile Facility Cleaning Requirements

John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply, discusses the company's manufacturing and supply strategy and network.

Pfizer Outlines Its Supply Strategy

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Quality Issues for Multiregional Clinical-Trial Materials

The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.

Assessment of Large-Sample Unit-Dose Uniformity Tests

The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.

Sizing Up the Global Market for Excipients

This risk-management case study focuses on assessing empty capsules.

PQRI Case Study (4): Process Deviation and Empty Product Capsules

Where are the new excipients, the new solubilisers and sustained release excipients?