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Audience: Pharmaceutical scientists in industry, government, and academia.
This book is well referenced and indexed. Each of the 16 chapters is written by experts and illustrated with figures, tables, and graphs. Anyone involved with new drug development, production, and control in the pharmaceutical industry would fine this title useful as well as graduate students and faculty in these areas. This would be a good acquisition for a graduate or research chemical or pharmaceutical library.
--E-Streams E-STREAMS Vol. 5, No. 6 - June 2002
On the whole this well written and thoroughly edited volume brings the reader up to date on a wide range of subjects pertaining to analytics in pharmaceutical industry.
--Alexander Nezlin, CTS Chemical Industries Ltd, Kiryat Malachi, Israel
Bioseparations frequently entail separations of proteins and related materials from biological matrices.' This book is planned to serve as a handbook of bioseparations, where the primary focus is separations of proteins; however, separations of other materials of interest such as nucleic acids and oligonucleotides are also covered to assist the reader in tackling their particular bioseparation problems. Included in this text is a chapter on the separation of monoclonal antibodies, as these materials have found numerous uses in the biopharmaceutical industry. As a matter of fact, in the last few decades, monoclonal antibodies and recombinant antibodies have become one of the largest classes of proteins that have received FDA approval as therapeutics and diagnostics.
Undeniably, biopharmaceuticals should be safe and effective. This must be demonstrated by effectively planned studies as well as documentation to the satisfaction of regulatory agencies. The young age of this industry is demonstrated by the fact that in 1985, the FDA issued a document entitled "Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology." In 1997 a similar document was issued for monoclonal antibodies. Also in 1997, the Center for Biologics Evaluation and Research (CBER) issued guidance on the preparation of a Biologics License Application (BLA). For the first time, manufacturers can file a BLA instead of an Establishment License Application (ELA) and a Product License Application (PLA). The BLA brings the drug and biotechnology therapeutics registration process closer together.
The CBER was established in 1987 as a spin-off of the FDA's Center for' Drugs and Biologics in response to a growing number of applications for new biotechnology products. "Guidelines," "Guidance," "Points to Consider," and other documents are available from CBER (Office of Training and Manufacturers Assistance, HFM-40, Rockville, MD, 20852. Information can be obtained by telephone at 800-835-4709 or by fax at 301-827-3844). It is important to keep current with the latest regulations. Generally, this information can be obtained from the FDA Web site.
A joint regulatory-industry initiative was taken to provide international harmonization of the drug approval process. The guidelines recommended by the International Conference on Harmonization (ICH) address quality, safety, and efficacy. The ICH issued draft guidelines on analytical validation procedures in 1996 and a document entitled "Draft Consensus Guidelines and Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products" in 1998. Further information relating to ICH can be found at the Web site ifpma.org of the International Federation of Pharmaceutical Manufacturers Association.
The contents of this book have been broadly classified into three sections:
|1||Modern Pharmaceutical Analysis: An Overview|
|2||Combinatorial Chemistry and High-Throughput Screening in Drug Discovery and Development|
|4||Degradation and Impurity Analysis for Pharmaceutical Drug Candidates|
|6||Solid Dosage-Form Analysis|
|7||Parenteral Dosage Forms|
|8||New Drug Delivery Systems|
|11||Setting Up Specifications|
|12||Validation of Pharmaceutical Test Methods|
|14||Analytical Methodology Transfer|
|15||Pharmaceutical Analysis Documentation|
|16||An Innovative Separation Platform: Electrophoretic Microchip Technology|