Preclinical safety evaluation of biopharmaceuticals : a science-based approach to facilitating clinical trials

Select an Action

Title:

Author:

Cavagnaro, Joy A.

ISBN:

9780470108840

Publication Information:

Hoboken, NJ : Wiley, 2008.

Physical Description:

xxvi, 1033 s. + color plate.

General Note:

Forward (Joy Cavagnaro and Anthony D. Dayan). PART I. BACKGROUND. Chapter 1 Biopharmaceuticals: Definition and Regulation (Lincoln Tsang, FlBiol and Nathan ). Chapter 2. Methods of Production of Biopharmaceutical Products and Assessment of Environmental Impact (Patricia Williams). PART II. PRINCIPLES OF PRECLINICAL DEVELOPMENT. Chapter 3. The Principles of ICH S6 and the Case-by-Case Approach (Joy Cavagnaro). Chapter 4. Implementation of ICH S6: European Perspective (Peter Ryle, and David Snodin). Chapter 5. Implementation of ICH S6: Japanese Perspective (Takahiru Nakazawa). Chapter 6. Implementation of ICH S6: US Perspective (Mary Ellen Cosenza). PART III. CURRENT PRACTICES IN PRECLINICAL DEVELOPMENT . Chapter 7. Comparison of Small Molecule vs. Large Molecule Development (early stage) (Christopher Horvath). Chapter 8. Comparability Assessment During Biopharmaceutical Clinical Development (Richard Lewis). PART IV. SELECTION OF RELEVANT SPECIES. Chapter 9. In Vitro/In Vivo Testing to.

Abstract:

Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials covers the entire clinical development continuum from selection of lead candidate to first in human studies to ultimate product approval. It provides an overview of the nature of biopharmaceuticals and the practice of preclinical safety evaluation, including regulations in the US, EU, and Japan.

Subject Term:

Clinical trials.

Biological products.

Preclinical drug evaluation.

Added Author:

Cavagnaro, Joy A.

Copies:

Available:*

Library	Material Type	Item Barcode	Shelf Number	Copy	Status
Searching... 1:IIEMSA	1:GEN-BOOK	33168025533262	615/.19 C376P 2008	1	Searching... Unknown

Bound With These Titles

On Order

Summary

"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies."
--From the Afterword by Anthony D. Dayan

Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials : Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.