Handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines. This practical handbookis needed in this area to serve pharmaceutical scientists who handle responsibilities in a variety of functions relating to the drug stability, including R&D, formulation, analytical development, QA/QC, regulatory affairs and production

• ISBN: 978-0-387-85626-1
• Editorial: Springer
• Encuadernacion: Cartoné
• Páginas: 330
• Fecha Publicación: 01/12/2008
• Nº Volúmenes: 1
• Idioma: Inglés