Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging and holding of dietary supplement products.

Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory.

Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques.

The second edition of Pharmaceutical Water: Systems Design, Operation, and Validation has been thoroughly revised and updated to cover all relevant aspects of pharmaceutical water technology in a clear and concise style. Learn More

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for traditional drug substances. This is the only guide available to tackle this subject in-depth. The new edition has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years.

The revised third edition of Drug Stereochemistry: Analytical Methods and Pharmacology has been updated to cover all aspects chiral drugs from the academic, governmental, industrial and clinical perspective. This one-stop text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisometric drugs.

The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products, tackles these challenges head on.

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products.