Delighted to have been a contributor to this super book with my colleagues Robert Lee, Laurie Goldman, Todd Wilson and Matthew Irick!
After two years of evening and weekend work, I'm delighted (and relieved) that our 900 page book "Specification of Drug Substances and?Products - Development and?Validation of Analytical Methods" is finally released! https://lnkd.in/gBkR3QJB https://lnkd.in/grq--Aup Over 70 experts (listed below) across the pharmaceutical industry have authored 40 chapters covering (almost) all aspects of analytical testing and specification setting, for example: -?test methods (universal tests, methods for specific dosage forms, bioanalysis) - types of molecules /routes of manufacturing (small molecules, biologics, cells & genes, oligonucleotides, antibodies, biosimilars, nanoparticles) - routes of administration / types of products (oral, parenteral, inhalation, topical, transdermal, ophthalmic, vaccines)? - development phases (clinical, marketing application, post approval)? - pharmacopoeia (USP, Ph. Eur., JP, BP, FB, IP, Ph. Int) - ICH Q1-Q14, M4, M7 - regulatory guidances/guidelines in different territories (US, EU, Japan, Brazil, ASEAN, Switzerland, UK, Canada, China, India, South Korea etc) - regulatory processes (meetings, submissions, amendments) - stability and shelf life for all climate zones (chapter authors by alphabetical order of last names) Andreas Abend, Sharad Agarwal, Nadim Akhtar, Kent Amsberry, Daniel W. Armstrong Steven Baertschi, Stéphane Baronnet Cristiana Campa, Barbara Capecchi, Ping Chen, Adrian Clarke, Ian Clegg Jennifer Dally, Jean-Fran?ois Dierick Steve Fields, Luis Francisco Flores-Ortiz, Gair Ford Gerald Gellermann, Laurie Goldman, Vivian Gray Brian Lingfeng He, Kim HuynhBa Matthew Irick Dhavalkumar Jain, Qin C. Ji, Huahua Jian Ema Kikovska-Stojanovska, Stephan Kirsch, Ryan Klein, Silke Klick Yin L., Thomas Larsson, Chris Latoz, Robert Lee, Katrin Liebelt, Martin Lindsj?, W John Lough Robert Mayer, Lori McCaig, Kristi McKenzie, Albert Mensah, Cecilia Qvist Michel, Myrna Monck, Christian Moreton, Kurt Moyer Lien Nguyen Petr Obrdlik, B. Olsen, Julia O'Neill Laura Pack, Ernest Parente, Ph.D., R.L. Phelps, Thomas Pohl, Chetan Pujara George R., Chris Riley, Michael Ruberto James Scull, PhD, Santoshi Sharma, Eric Sheinin, Pamela Smith Mohsen Talebi, Ph.D., Kailas Thakker, Patrick Tishmack, Gillian Tocci Jon Valgeirsson, Keila Ventura Linna Wang, Tao Wang, Chloe Westley, Todd Wilson Long Yuan Huge thanks also to countless other experts that I can't list, but who have reviewed the manuscripts and provided valuable comments.