Impact of Anti-Drug Antibodies in Preclinical Pharmacokinetic Assessment

The administration of human biotherapeutics is often associated with a higher incidence of immunogenicity in preclinical species. The presence of anti-drug antibodies (ADAs) in the test samples can affect the accurate me...

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...

Predicting Drug–Drug Interactions: An FDA Perspective

Pharmacokinetic drug interactions can lead to serious adverse events, and the evaluation of a new molecular entity’s drug–drug interaction potential is an integral part of drug development and regulatory...

Are Physiologically Based Pharmacokinetic Models Reporting the Right Cmax? Central Venous Versus Peripheral Sampling Site

The online version of this article (doi:10.1208/s12248-015-9796-7) contains supplementary material, which is available to authorized users.

Similarities and Differences of International Guidelines for Bioequivalence: an Update of the Brazilian Requirements