Description
Book SynopsisHow to hone your analytical skills and obtain high-quality data in the era of GMP requirements With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide.
Trade Review"...chemists...explain how to comply with US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly." (SciTech Book News, Vol. 24, No. 4, December 2000)
"Anyone...involved in training exercises and in...gathering...pertinent material from different sources will find this book very helpful." (Journal of Medicinal Chemistry, Vol. 44, No. 21, 2001)
"I recommend this book for anyone who recognizes a need for more and better training of pharmaceut9ical laboratory analysts...a remarkably rich resource." (Clinical Chemistry, Vol. 48, No. 3, 2002)
"...provides a much needed perspective on the role of analytical chemistry in the pharmaceutical industry and is a welcome addition...a useful resource." (Journal of Chemical Education, December 2002)
Table of ContentsThe Laboratory Analyst's Role in the Drug Development Process (J. Crowther, et al.).
Laboratory Controls and Compliance (H. Avallone).
The USP, ICH, and Other Compendial Methods (J. Feldman).
Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).
Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).
Spectroscopy (P. Abauf & A. Melveger).
Chromatographic Principles (J. Miller).
Gas Chromatography (J. Miller & H. McNair).
Liquid Chromatography: Basic Overview (L. Polite).
HPLC Column Parameters (R. Hartwick).
Dissolution (R. Kirchhoefer & R. Peeters).
Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).
Some Principles of Quantitative Analysis (J. Miller).
Laboratory Data Systems (R. McDowall).
Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).
Appendices.
Index.
