A Rational, Systematic Approach for the Development of Vaccine Formulations

With the continuous emergence of new infectious diseases and new strains of current diseases, such as the novel H1N1 influenza in 2009, in combination with expanding competition in the vaccine marketplace, the pressure t...

Use of Dried Blood Spots in Drug Development: Pharmacokinetic Considerations

Dried blood spots are increasingly being used in drug development. This commentary considers the pharmacokinetic issues that arise and compares these with those attached to plasma, the mainstay matrix. A common implicit...

AAPS-FDA workshop white paper: Microdialysis principles, application, and regulatory perspectives report from the Joint AAPS-FDA Workshop, November 4–5, 2005, Nashville, TN

A Priori Identifiability of Target-Mediated Drug Disposition Models and Approximations

The online version of this article (doi:10.1208/s12248-015-9795-8) contains supplementary material, which is available to authorized users.

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

Immunogenicity assessment is important for biological products due to potential impacts of immunogenicity on safety and efficacy. We reviewed the prescribing information and the FDA’s clinical pharmacology review...