Formulation and analytical development for low-dose oral drug products

There are many special considerations involved when working on low-dose drug products. These involve all ends of development, from chemical analysis of thedrug to manufacturing the low dosage form. At all stages, there are particular regulatory requirements that pharmaceutical scientists must be aware of. Although many references related to such issues are scattered across books and journals, there has not yet been an effort to put them together systemically discuss those issues within a single book. This book provides current informationon formulation, manufacturing process and analytical method development, containment strategies, and regulatory concerns for low-dose oral product development. Many practical case studies illustrate the real world of low-dose drug product development.

• ISBN: 978-0-470-05609-7
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 461
• Fecha Publicación: 10/03/2009
• Nº Volúmenes: 1
• Idioma: Inglés