Cover Stories

Posted By Linda Brown
Found In Microsite: AAPS News Magazine
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., ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
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 ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
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 ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
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 ...
Posted By Matt Baughman
Found In Microsite: AAPS News Magazine
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 ...