TY - BOOK AU - Akers, Michael J. TI - Sterile drug products: formulation, packaging, manufacturing, and quality SN - 9780849339936 AV - RS 199.S73 .A54 2010 PY - 2010/// CY - New York PB - Informa Healthcare KW - DOSAGE FORMS STANDARDS N1 - Includes bibliographical references and index; Introduction, scope, and history of sterile products -- Characteristics of sterile dosage forms -- Types of sterile dosage forms -- Sterile product packaging systems -- Overview of product development -- Formulation components (solvents and solutes) -- Sterile products packaging chemistry -- Formulation and stability of solutions -- Dispersed systems -- Formulation of freeze-dried powders -- Overcoming formulation problems and some case studies -- Overview of sterile product manufacturing -- Contamination control -- Sterile manufacturing facilities N2 - This book is based primarily on courses that I thought on the basic principles of sterile dosage formulation, packaging, manufacturing, and quality control and assurance over a span of 35 years ER -