Cover Stories

Mechanistic PKPD models support FIH trial design, development of targeted immunotherapies, and understanding complex PK properties and covariates.  By Fei Hua, Ph.D.; Daniel Kirouac, Ph.D.; Lore Gruenbaum, Ph.D.; John Burke, Ph.D.; Joshua Apgar, Ph.D., ...

Integrating a holistic approach toward product quality and safety in the development of biologic drug products for parenteral use. By Hanns-Christian Mahler, Ph.D., Satish K. Singh, Ph.D., Sven Stegemann, Ph.D., all Lonza AG Biologics, also known as ...

New functionality for small molecule therapeutics can advance drug development. By John Morrison, Ph.D., Bristol-Myers Squibb, and Steven Louie, Amgen The pharmaceutical industry continues to evolve, developing strategies to take advantage of novel ...

With products ranging in scope and complexity, implementing even a streamline regulatory framework may be challenging. By Stefan Leiner, Ph.D., and Christoph Kreher, Ph.D., Boehringer Ingelheim Pharma GmbH & Co. KG   In the European Union (E.U.), the ...

Global input on harmonizing bioanalytical method validation solidified scientists’ vision and outlined universal challenges with existing guidelines. By Faye Vazvaei, M.S., Roche Innovation Center New York; Lakshmi Amaravadi, Ph.D., Shire Plc; Lindsay ...