Analytical Research and Development

The analytical research and development (R D) unit is often responsible for the preparation and vahdation of test methods. The R D lab is not faced with the same pressures for rapid analysis as the QC unit, where pending results often hold up production. In addition, R D often assigns personnel to specific instmments or techniques, whereas QC generally requires technicians to perform varied analyses. This leads to an expertise on the part of analytical chemists and technicians which is difficult to duphcate in QC. Therefore the R D test method should be mgged enough to withstand the different environment of the QC lab and stiU provide vahd results. 

Abbott Laboratories, Pharmaceutical Analytical Research and Development, North Chicago, IL... 

We would like to thank all of the authors for their valuable efforts in making this book serve as a definitive reference source on CE for laboratory analysts, researchers, managers/ executives in industry, academia, and government who are engaged in various phases of analytical research and development or in quality control. 

Jeffrey T. Kivi Department of Analytical Research and Development, Ross Products Division, Abbott Laboratories, Columbus, Ohio... 

James McShane, PhD, MS Pharmaceutical and Analytical Research and Development Eisai Inc. 

From Analytical Research and Development (AR D) to Quality Control (QC) Lab of the Commercial Organization... 

Dept, of Analytical Research and Development Hoffinann-La Roche Inc. 

Analytical Research and Development, Sandoz Pharma, Basel, Switzerland... 

Daniyie Giron / Analytical Research and Development, Sandoz Pharma, Basel, Switzerland Samuel V. Givens / Hoffmann-La Roche, Inc., Nutley, New Jersey, U.S.A. 

We do hope that all those active in the pharmaceutical industry (in particular in analytics, research and development, quality control or related areas), ancillary industry, public health authorities or public health labs, regulatory authorities, universities, forensic medicine etc. will benefit from the use of this new and convenient collection of spectra on CD-ROM. 

Karen M. Alsante (361) Pfizer Global Research and Development Division, Analytical Research and Development Department, Groton, CT 06340 Steven W. Baertschi (89) Eli Lilly and Company, Indianapolis, IN 46285 Ronald Bates (231) Pfizer Global Research and Development Division, Bioprocess Research and Development Department, Groton, CT 06340... 

Hugh J. Clarke (145) Pfizer Global Research and Development Division, Analytical Research and Development Department, Groton, CT 06340... 

The importance of analytical transfer was recently underscored by the Analytical Research and Development Steering Committee of the Pharmaceutical Research and Manufacturers Association (PhRMA) at their annual workshop. At this meeting, representatives from PhRMA member companies met with facilitators to draft an acceptable analytical practice (AAP) that will function as a suitable template for successful method transfer. Both facets of technology transfer have been discussed in this book. 

Pharmaceutical Research and Manufacturers Association Analytical Research and Development Workshop, Wilmington, DE, September 20, 2000. 

Within the analytical research and development (R D) unit, specifications and methods for clinical trial materials are approved and results from shortterm stability evaluations are reported. Method validation is completed for critical validation parameters for those methods used in release and stability testing of the clinical materials. Impurities and degradation products are tabulated for the toxicology and clinical batches to assure the safety of the materials for human use. 

These principles are especially critical to the analytical support group, either analytical research and development or quality control. 

This text fills the need for a handbook that is current with respect to the philosophy of analytical chemistry support for drug discovery, development, and post-market support. It is our intention to present the role of analytical research and development as a part of the overall process. For this reason, the chapters are organized in more of a process-driven manner rather than pure function or technique. In all cases, a large number of references are provided for those readers desiring a more in-depth discussion of a particular subject. 

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