Author: Jerry Calver Ph.D.
Edition:
Publisher: CreateSpace Independent Publishing Platform
Binding: Paperback
ISBN: 1456545086
Biologics: How to get your biological product to market and keep it there
Sub-Title : How to get your Biologic Product to Market and Keep It There. Medical books Biologics. The information provided in this book is to close the gap that exists in getting a product from proof of concept stage to commercialization (a Licensed product).Details on production, control and regulation of biologics include pre-clinical, GLP, clinical GCP and GMP. Validations of premises, equipment, processes and methods are covered. Detailed suggestions are provided to comply with inspection observations concerning GMP and product requirements Medical books .
Medical Book Biologics
The information provided in this book is to close the gap that exists in getting a product from proof of concept stage to commercialization (a Licensed product).Details on production, control and regulation of biologics include pre-clinical, GLP, clinical GCP and GMP. Validations of premises, equipment, processes and methods are covered. Detailed suggestions are provided to comply with inspection observations concerning GMP and product requirements. How to fill in Clinical Trial Applications and New Drug Submissions as to reviewer comments is also covered. CTD requirements as established by ICH are thoroughly examined. Prequalification requirements by the World Health organization (WHO) for vaccines and how to get approval are included.
