Home | Publications | Production / Manufacturing

Production / Manufacturing

Handbook of Pharmaceutical Manufacturing Formulations - Vol 6 of 6

Sterile Products

Publication Date April 2007
Publisher CRC Press
Product Type Book
Pages 384
ISBN Number 849317517
Product Code CRC097

Ask a question about this product?

Price £195.00 approximately: $364 \| €247
add PRINT to basket order by FAX
	view basket
	go to checkout

Summary

This publication :-

Maintains the largest reference on pharmaceutical formulations
Lists readily accessible formulations as chemical entities, dosage forms or pharmacological classifications
Provides instant substantial time and cost savings in pharmaceutical research and development
Speeds generic drug formulation regulatory submissions

The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, 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 sterile products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms.

Content

Sterile Manufacturing Practice

Inspection of Sterile Product Manufacturing Facilities
New Drug Application for Sterilized Products
Manufacturing Formulations Template

Sterile Pharmaceutical Formulations

Entries are arranged in alphabetical order of drug entity
Cross-referenced index allows sorting by the dosage form and by pharmacological class