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Production / Manufacturing |
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Handbook of Pharmaceutical Manufacturing Formulations - Vol 5 of 6
Over-the-Counter Products
Publication Date April 2007
Publisher CRC Press
Product Type Strategic Report
Pages 368
ISBN Number 849317509
Product Code CRC101
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Summary
This publication :-
- Speeds generic drug formulation regulatory submissions
- Lists readily accessible formulations as chemical entities, dosage forms or pharmacological classifications
- Provides instant substantial time and cost-savings in research and development
The fifth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers over-the-counter products, which include formulations of products classified by the US FDA under OTC category, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing OTC products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.
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Content
Preservation of Pharmaceutical Products
Preservative Testing
Prodrugs
Product License Applications and Establishment License Applications for Biological Products
Project Management
Protein Binding of Drugs
Pyrogens and Pyrogen Testing
Quality Assurance of Drug Prodcts
Radiation Sterilization of Drugs
Radiochemical Methods of Analysis
Receptors for Drugs
Rectal Administration and Absorption of Drugs
Registration of Drugs
Pheology of Pharmaceutical Systems
Robotics in the Pharmaceutical and Biomedical Laboratory
Salt Forms of Drugs and Absorption
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