Features of Handbook of Pharmaceutical Manufacturing Formulations:
- Supplies the largest reference on pharmaceutical formulations
- Lists readily accessible formulations as chemical entities, dosage forms or pharmacological classifications
- Provides substantial time and cost savings in pharmaceutical research and development
- Covers issues related to generic manufacturing of drugs including cGMP compliance, pre-approval inspections, stability testing
- ...and more!
Pharmaceutical formulations remain as much an art today as they have evolved into complex science. With exponential growth of generic formulations, the need for ready formulations has increased.
An authoritative practical guide in the art and science of formulating drugs, the six-volume handbook contains the Bill of Materials and Manufacturing Directions for over 2000 drug formulations, including a number of biotechnology and patented drugs.
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 30-plus years of experience in pharmaceutical formulations.
Each volume of the series is divided into two parts:
- the section on regulatory and manufacturing guidelines
- the section on formulations
The series provides chapters on issues related to generic manufacturing of drugs including:
- cGMP compliance
- pre-approval inspections
- stability testing
- bioequivalence testing
- packaging commodity development
- changes to aNDAs
- SUPAC for equipment
- and more
Each category of drug formulations, as classified in a separate volume, is analyzed for the common difficulties in formulating drugs.
This 6-Volume Set is the first of its kind published in the pharmaceutical literature and is a must collection for all pharmaceutical manufacturers, educational institutions and regulatory authorities.
Companies with large formulation teams will find this series an excellent platform for benchmarking their own products and the generic companies will find it an excellent source of information prior to embarking on formulating drugs coming off patent; it will mean getting on the filing of the aNDAs in the shortest possible time.
TOP REASONS TO PURCHASE DR. NIAZI'S SIX-VOLUME SET
- 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 ORGANISED 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 agents.
- CRITICAL GUIDELINES - on how to file aNDAs in the shortest possible tome, 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 over 35 years of experience
in pharmaceutical formulations.