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Cover Story Achieving a Harmonized Guideline for Bioanalytical Method Validation: ICH M10 By Faye Vazvaei, M.S., Roche Innovation Center New York; Lakshmi Amaravadi, Ph.D., Shire Plc; Lindsay King, Ph.D., Pfizer Inc.; Philip Timmerman, European Bioanalysis ...

Cover Story A Small Molecule Renaissance? Teaching an Old Modality New Tricks By John Morrison, Ph.D., Bristol-Myers Squibb, and Steven Louie, Amgen New functionality for small molecule therapeutics can advance drug development.    Student Member ...

Cover Story Regulatory Requirements for Drug-Device Combinations: Are We Clear? By Laura O’Brien, Ph.D., Boehringer Ingelheim Pharmaceuticals, Inc.; Nina Cauchon, Ph.D., R.A.C., Amgen Inc.; Willy Liou, M.S., R.A.C., Amgen Inc.; Tushar Mukherjee, Ph.D., ...

Cover Story Moving toward Clinically Relevant Dissolution Specifications By Kenneth Norris, Pfizer Inc.; Dorys Argelia Diaz, Pfizer Inc.; Mohan Ganapathy, Merck & Co. Inc.; Lynn Gold, Camargo Pharmaceutical Services; and Ling Zhang, Pfizer Inc. Ensuring ...

Cover Story Micro- and Nanoparticulate Cancer Vaccines: A Vision for the Future By Lipika Chablani, Ph.D., St. John Fisher College Micro/nanoparticles show promise for immunotherapy against cancer.   Professional Development Tap into NIH Funding ...