The only encyclopedia that specifically focuses on biopharmaceutical statistics, the 3rd Edition provides a well-balanced summary of current regulatory requirements, along with a comprehensive and unified presentation of designs and analyses used at different stages of biopharmaceutical and clinical research and development. This is the definitive statistical guide for the entire pipeline of drug/pharmaceutical product development: from non-clinical and pre-clinical assessments and manufacturing processes through to clinical trials, regulatory processes and postmarketing surveillence.
Thoroughly exploring emerging technologies, concepts, and trends, this edition incorporates 89 brand new chapters on subjects such as biomarker development, target clinical trials and follow-on biologics. Previous contents of this title have been revised and updated, and cover topics ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials and medical devices. The encyclopedia also includes popular topics that are currently under discussion within regulatory agencies and the pharmaceutical/biotech industry, such as pharmacoeconomics, reproducibility and probability in clinical research.
Available in hard copy and online formats, this highly specialised book is a must-have resource for pharmaceutical R&D departments as well as for statisticians and researchers who work on clinical trials regulated by the FDA.
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
Descrizione libro CRC Press, 2003. Hardcover. Condizione libro: New. 2. Codice libro della libreria DADAX0824742613
Descrizione libro CRC Press, 2003. Hardcover. Condizione libro: New. book. Codice libro della libreria 0824742613
Descrizione libro Condizione libro: Brand New. New. US edition. Customer Satisfaction guaranteed!!. Codice libro della libreria SHAK55184
Descrizione libro Condizione libro: New. New. US edition. Perfect condition. Ship by express service to USA, Canada, Australia, France, Italy, UK, Germany and Netherland. Customer satisfaction our priority. Codice libro della libreria ABE-190516-55184
Descrizione libro Condizione libro: Brand New. Brand New Original US Edition, Perfect Condition. Printed in English. Excellent Quality, Service and customer satisfaction guaranteed!. Codice libro della libreria AIND-58652
Descrizione libro Condizione libro: New. Brand New Original US Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery. Codice libro della libreria AUSB-58652
Descrizione libro Informa Healthcare, 2003. Hardcover. Condizione libro: New. Codice libro della libreria SONG0824742613
Descrizione libro Taylor & Francis Group. Condizione libro: New. pp. 1000. Codice libro della libreria 7376994