Lynn D. Torbeck

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

A change in terminology could emphasize patient protection.

Real-time experimentation may offer continuous process improvement.

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

Applying current principals to traditional factorial designs.

Understanding the differences between convenience, target, and self-selected samples.

Where is the variability coming from and what have we done to minimize it?

Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.

Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.