Drug Development

Articles

The manufacturing process, which influences a drug's safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

Reducing Supercooling during the Lyophilization of Biologicals

Reading PharmTech's October article on Critical Challenges to Implementing QbD gave me the impression that we might have the road map to Moksha or Nirvana. Unfortunately that was not meant to be.

Understanding QbD Requires Basic Fundamentals

Robert Lionberger is a chemist at the Office of Generic Drugs at the US Food and Drug Administration.

Gordon Johnston is vice-president of regulatory sciences at the Generic Pharmaceutical Assocation.

Lawrence X. Yu is deputy director for science in the Office of Generic Drugs (OGD) at the US Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855.

Gary Buehler is director of the Office of Generic Drugs at the US Food and Drug Administration.

Michael C. Olson is a chemist at the Office of Pharmaceutical Science at FDA.

Helen Winkle is director of the Office of Pharmaceutical Science.

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Quality by Design for Generic Drugs

Like life, the workplace also can have many surprises.

Sneaky and Suspicious

Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing.

Global Regulatory Submissions for QbD: Wyeth's Experience in the CMC Pilot

Thomas S. Chirkot Ph.D, P.E., is a near-infrared sales specialist at ThermoFisher Scientific, 4410 Lottsford Vista Road, Lanham, MD 20706, tel. 570.909.7657.

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

The Relevance of Continuous Solid Oral Dosage Processing and NIR Spectroscopy In Meeting the Needs of QbD and PAT

Angie Drakulich was editorial director of Pharmaceutical Technology.

Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material.

Critical Challenges to Implementing QbD: A Q&A with FDA

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

Building a Framework for Quality by Design

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

Process and Scaling