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- 000 02815cam a2200313 i 4500
- 008 100722s2024 nyua b 001 0 eng
- 020 __ |a 9781032919119 |q (paperback)
- 040 __ |a DNLM/DLC |b eng |c DLC |d BTCTA |d BAKER |d YDXCP |d NLM |d C#P |d BDX |d IG# |d UKMGB |d OCLCF |d M6U |d CRCPR |d GBVCP |d OCLCQ |d THHCU |d CNUTO |d THHCU |d ESU |d OCLCO |d OCL |d OCLCO |d OCLCL |d OCLCA |e rda
- 050 00 |a RS199.S73 |b A44 2010
- 060 00 |a W1 |b DR893B v.208 2010
- 100 1_ |a Akers, Michael J., |e author.
- 245 10 |a Sterile drug products : |b formulation, packaging, manufacturing, and quality / |c Michael J. Akers.
- 260 __ |a New York : |b Informa Healthcare, |c 2024.
- 300 __ |a ix, 505 pages : |b illustrations ; |c 27 cm.
- 336 __ |a text |b txt |2 rdacontent
- 337 __ |a unmediated |b n |2 rdamedia
- 338 __ |a volume |b nc |2 rdacarrier
- 490 1_ |a Drugs and the pharmaceutical sciences
- 504 __ |a Includes bibliographical references and index.
- 520 __ |a 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.
- 650 _0 |a Drugs |x Sterilization.
- 650 _0 |a Quality control.