Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesRegulatory Nonclinical Statistics

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries: Regulatory Nonclinical... [The nonclinical statistics teams in the Center of Drug Review and Research of the Food and Drug Administration (FDA) conduct regulatory reviews, statistical consultation, and statistical methodology development in nonclinical regulations. In this chapter, we provide a brief description of the two teams and provide two examples in statistical research development. In the first example, we describe the historical background and evolution of statistical methodology development in the last 20 years for the acceptance sampling and lot evaluation procedures on dose content uniformity involved with FDA Chemistry Manufacturing, and Control (CMC) Statistics Team. In the second example, we illustrate the research activities of Pharmacological/Toxicological (Pharm-Tox) Statistics Team at FDA with the background and evaluation of multiple pairwise comparisons in animal carcinogenetic studies.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesRegulatory Nonclinical Statistics

Download PDF
13 pages

Loading next page...
 
/lp/springer-journals/nonclinical-statistics-for-pharmaceutical-and-biotechnology-industries-4DbkM0VCsU
Publisher
Springer International Publishing
Copyright
© Springer International Publishing Switzerland 2016
ISBN
978-3-319-23557-8
Pages
19 –31
DOI
10.1007/978-3-319-23558-5_2
Publisher site
See Chapter on Publisher Site

Abstract

[The nonclinical statistics teams in the Center of Drug Review and Research of the Food and Drug Administration (FDA) conduct regulatory reviews, statistical consultation, and statistical methodology development in nonclinical regulations. In this chapter, we provide a brief description of the two teams and provide two examples in statistical research development. In the first example, we describe the historical background and evolution of statistical methodology development in the last 20 years for the acceptance sampling and lot evaluation procedures on dose content uniformity involved with FDA Chemistry Manufacturing, and Control (CMC) Statistics Team. In the second example, we illustrate the research activities of Pharmacological/Toxicological (Pharm-Tox) Statistics Team at FDA with the background and evaluation of multiple pairwise comparisons in animal carcinogenetic studies.]

Published: Dec 29, 2015

Keywords: Chemistry manufacturing and control; Acceptance sampling; Content uniformity; Pharmacological/toxicological studies

There are no references for this article.