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May/June 2016 | Volume 19, Issue 4


COVER FEATURES


14 DRUG DELIVERY FDA’s Regulatory Science Program for Generic PLA/PLGA-Based Drug Products Yan Wang1


, Wen Qu2 , Stephanie H. Choi1


1Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA 2Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA


40 MICROBIOLOGY


Developability Predictions for Antibody Engineering and Risk Mitigation Daniel Seeliger1*


, Timothy D. Fenn2 , and Anne R. Karow-Zwick3


1Discovery Research, Lead Identification and Optimization Support, Boehringer Ingelheim, Biberach, Germany 2Discovery Research, Immune Modulation and Biologics Discovery, Boehringer Ingelheim, Ridgefield, CT, USA 3Global Bioprocess and Pharmaceutical Development, Boehringer Ingelheim, Biberach, Germany


52 SPECTROSCOPY


Enantioselective Raman Spectroscopy – A new tool for process monitoring in the pharmaceutical industry? Johannes Kiefer Technische Thermodynamik, Universität Bremen


www.americanpharmaceuticalreview.com |


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