Parenteral Medications, Fourth Edition

4. Auflage 2019
ISBN: 978-1-4987-1914-8
Verlag: CRC Press

Buch, Englisch, 1144 Seiten, Format (B × H): 210 mm x 280 mm, Gewicht: 3380 g

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration.

Key Features:

- Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms

- Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration

- Includes 13 new chapters and updated chapters throughout

- Contains the contributors of leading researchers in the field of parenteral medications

- Uses full color detailed illustrations, enhancing the learning process

The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Zielgruppe

Academic and Professional Practice & Development

Autoren/Hrsg.

Nema, Sandeep

Ludwig, John D.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

Parenteral Drug Administration and Delivery Devices. Molecular Selection, Formulation Design, and Characterization. Specialized Drug Delivery Systems. Primary Packaging, Container Closure Integrity and Extractables. Facility Design and Environmental Control. Sterilization and Pharmaceutical Processing. Quality Testing and Regulatory Requirements.

Über Autor(innen)

SANDEEP NEMA, PhD, is Executive Director, Biotherapeutics Pharmaceutical Sciences at Pfizer where he is responsible for all pre-proof of concept biologics projects from discovery up to Phase 3. Sandeep earned a PhD in 1992 and since then has been involved with the development of small molecule, vaccine, protein, and cell and gene therapy drugs via parenteral delivery first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia). He has been lead formulator for four launched products. Dr. Nema is a Certified Regulatory Affairs Professional and is active in AAPS and PDA, where he regularly teaches courses and organizes symposiums. He is an adjunct professor at the University of Tennessee. In addition, he has served as a Steering Committee Member for the Handbook of Pharmaceutical Excipients.

JOHN D. LUDWIG, PhD, is Senior Vice President, Medicinal Sciences, Worldwide Research and Development at Pfizer, where he is responsible for medicine design, biomedicine design, pharmaceutical sciences, and global clinical supply. Ludwig earned a BS in pharmacy and a PhD in pharmaceutics at the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle Inc., Pharmacia Inc., and Pfizer Inc. Dr. Ludwig is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to the development of three professional training courses and serves regularly as a course instructor at PDA.