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Online Public Access Catalogue

题名/责任者:

Sterile drug products : formulation, packaging, manufacturing, and quality / Michael J. Akers.

出版发行项:

New York : Informa Healthcare, 2024.

ISBN:

9781032919119

载体形态项:

ix, 505 pages : illustrations ; 27 cm.

丛编说明:

Drugs and the pharmaceutical sciences

个人责任者:

Akers, Michael J., author.

论题主题:

Drugs-Sterilization.

论题主题:

Quality control.

中图法分类号:

R944.5

书目附注:

Includes bibliographical references and index.

摘要附注:

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. 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.

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