SAVE! when you purchase this new set of pharmaceutical formulations from C.H.I.P.S.
Revised and expanded, this new six-volume set compiles volumes from FDA New Drug Applications, patent applications, and sources of generic and proprietary formulations to cover issues concerning drug manufacturing.
Ordering Information
Features of
Handbook of Pharmaceutical Manufacturing Formulations, Second edition:
- Comprehensive Content—revised and updated material on the Bill of Materials and Manufacturing Directions for over 2,000 manufacturing-scale stable formulations with the most essential information needed to develop commercial batches.
- Well-Organized into several distinct parts—worldwide regulatory/manufacturing guidelines, excipient database, performance specifications and manufacturing formulations—makes this an indispensible collection for pharmaceutical manufacturers, educational institutions, and regulatory agencies.
- Critical Guidelines—on how to file aNDAs in the shortest possible time, helping companies to reduce the research and development cycle and the cost of matrixing formulations. Emphasis is placed on the US, European, and WHO guidelines on cGMP compliant manufacturing, particularly the newly-enacted risk-based guidelines.
- Excellent Platform—for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
- Expert Authorship—Dr Niazi supplements facts with more than 35 years of experience in pharmaceutical formulations.
The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications and other sources of generic and proprietary formulations, all supplemented by his 35+ years of experience in pharmaceutical formulations.
Divided coveniently into serveral parts—worldwide regulatory/manufacturing guidelines, databases to allow proper selection of safe levels of excipients, available release specifications and commercially-scaled formulations—each volume covers the most critical elements, such as:
- Dosage-form dependent cGMP compliance issues including facility design
- Critical and common factors in formulating specific drug delivery systems
- Preparing for pre-approval inspections
- Commodity packaging development
- Stability/bioequivalence testing
- Difficulties in formulating drugs
- Changes to approved marketing authorization applications (e.g. aNDAs)
- SUPAC for equipment
- Accessible formulations as chemical entities, dosage forms, or pharmacological classifications
- and more
A must-have for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is the platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
The largest reference on pharmaceutical formulations, this text provides guidelines on filing aNDAs efficiently, helping pharmaceutical companies to cut costs in research and development.