Sterile Drug Products
Author : Michael J. Akers
Publisher : CRC Press
Total Pages : 516
Release : 2016-04-19
ISBN 10 : 9781420020564
ISBN 13 : 1420020560
Language : EN, FR, DE, ES & NL

Sterile Drug Products Book Description:

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.


Sterile Drug Products
Language: en
Pages: 516
Authors: Michael J. Akers
Categories: Medical
Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality steril
Guideline on Sterile Drug Products Produced by Aseptic Processing
Language: en
Pages: 43
Authors:
Categories: Asepsis and antisepsis
Type: BOOK - Published: 1987 - Publisher:

Guideline on Sterile Drug Products Produced by Aseptic Processing
Language: en
Pages: 86
Authors: Food and Drug Administration, Rockville/Md
Categories:
Type: BOOK - Published: 1987 - Publisher:

Guideline on Sterile Drug Products Produced by Aseptic Processing
Language: en
Pages: 43
Authors: Center for Drugs and Biologics (U.S.)
Categories: Asepsis and antisepsis
Type: BOOK - Published: 1987 - Publisher:

Guidance for industry
Language: en
Pages: 59
Authors:
Categories: Asepsis and antisepsis
Type: BOOK - Published: 2004 - Publisher:

Guidelines on Sterile Drug Products Produced by Aseptic Processing
Language: en
Pages: 43
Authors:
Categories:
Type: BOOK - Published: 1987 - Publisher:

Sterile Pharmaceutical Products
Language: en
Pages: 428
Authors: KennethE. Avis
Categories: Medical
Type: BOOK - Published: 2018-03-29 - Publisher: Routledge

Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing indust
Sterile Processing of Pharmaceutical Products
Language: en
Pages: 368
Authors: Sam A. Hout
Categories: Technology & Engineering
Type: BOOK - Published: 2021-12-31 - Publisher: John Wiley & Sons

Describes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and ma
Sterile Pharmaceutical Products
Language: en
Pages: 428
Authors: KennethE. Avis
Categories: Medical
Type: BOOK - Published: 2018-03-29 - Publisher: Routledge

Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing indust
Handbook of Pharmaceutical Manufacturing Formulations
Language: en
Pages: 464
Authors: Safaraz K. Niazi
Categories: Medical
Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reaso