Sterile Drug Products: Formulation, Packaging, Manufacturing and QualityКНИГИ » ЗДОРОВЬЕ И МЕДИЦИНА
Автор: Michael J. Akers Название: Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality Издательство: CRC Press Год: 2010 ISBN: 978-0849339936 Серия: Drugs and the Pharmaceutical Sciences (Book 208) Язык: English Формат: pdf Размер: 14,1 mb Страниц: 516
The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common.
This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology:
- Product development, including formulation, packaging, and process development. - Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. - Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form - Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.
Modern Pharmaceutics, 4th Edition Автор: Gilbert S. Banker and Christopher T. Rhodes Название: Modern Pharmaceutics, 4th Edition Издательство: CRC Press Год: 2002 ISBN: 9780824706746...
Protein Formulation and Delivery Автор: Eugene J. McNally Название: Protein Formulation and Delivery Издательство: CRC Press Год: 2000 ISBN: 9780824778835 Серия: Drugs and the...
Навигация
Вход на сайт
Реклама
Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality 
