A Review of Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trial
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A Review of Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials David M. Cocchetto, PhD US Regulatory Affairs, GlaxoSmithKline, Research Triangle Park. North Carolina
Correspondence Address David M. Cocchetto. PhD. US Regulatory Affairs. GlaxoSmithKline,5 Moore Drive, Research Triangle Park. NC 27709 (email: david.mcocchetto@ &corn).
CAVAGNARO, JOYA.: PRECLINICALSAFETY EVALUATION OF BIOPHARMACEUTICALS: A SCIENCE-BASEDAPPROACH TO FACILITATING CLINICAL TRIALS. New York, John Wiley & Sons, August 2008, 1,033 pages. Over the last 10 to 15 years, the substantial increase in effort to discover and develop biopharmaceuticals as medicines for human use has increased the need for a compilation of key information on nonclinical safety assessment of investigational biopharmaceuticals. Dr. Joy Cavagnaro has tackled this important topic to compile and edit a contemporary volume of reference information on nonclinical safety evaluation of biopharmaceuticals. Drawing on her more than 25 years of experience in multiple sectors of biopharmaceutical development, Dr. Cavagnaro has applied her experience to recruit a group of experts to provide chapters in this volume. It is a substantial contribution to the field. The 40 chapters of the book, encompassing approximately 1,000 pages, address the chronology of biopharmaceutical development from species selection during preclinical safety assessment to various types of toxicology studies needed to support progression of clinical trials in humans with a vision to new product registration. This text addresses biopharmaceuticals as
biotechnology-derived products that may be of medicinal value in patient care. The scientific scope of this volume is quite broad, addressing topics such as reproductive toxicology, immunogenicity assessment, and carcinogenicity assessment. In addition, a group of 14 chapters provides over 300 pages of information on preclinical safety considerations by product class (including attention to peptides, monoclonal antibodies, blood products, immunotoxins, and viral vaccines). Developers of various classes of products should find the contents instructive to discerning the key points to consider in the plan for nonclinical safety assessment of a specific biopharmaceut ical. Dr. Cavagnaro and her contributors have organized this volume in an understandable manner that facilitates its potential use as a textbook or as a reference. The book is organized into the following parts:
Part I. Background Part 11. Principles of Preclinical Development Part 111. Current Practices in Preclinical Development Part IV. Selection of Relevant Species Part V. Safetyfloxicity Endpoints Part VI. Specific Considerations Based on Product Class Part VII. Preclinical Study Design, Implementation, and Analysis
Drug Information Journal. Vd.43, pp. 109-110.2009 0092-8615/2009 Downloaded from dij.sagepub.com KAI NAN UNIV on May 2, 2015 Prinfed in the USA. All rights raoved. Copyghf 0 2009 DrugatInformation Associafion. Inc.
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