CRC Press Current Topics in Nonclinical Drug Development: Volume 1

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development. About the Author Pritam S. Sahota, Global ToxPath LLC, Kennewick, Washington, USA, has extensive experience in toxicologic pathology and drug development within the framework of nonclinical safety assessment of pharmaceuticals. Dr. Sahota was previously Executive Director and Head of Pathology, Preclinical Safety, at Novartis Pharmaceuticals, East Hanover, New Jersey. He obtained his veterinary medicine (BVSc) and veterinary pathology degrees (MSc and PhD) from Punjab Agricultural University, India. He is a diplomate of the American Board of Toxicology. After receiving his PhD in 1976, he started working as a toxicologic pathologist at Dawson Research Corporation (DRC), Orlando, Florida, a contract research organization involved in the preclinical safety evaluation of drugs and chemicals. At DRC, he received increasing responsibility over the next 10 years (toxicologic pathologist, senior toxicologic pathologist, and scientific director). As a scientific director, he was responsible for the scientific aspects of pathology as well as toxicology at DRC. While working briefly for Dynamac Corporation, Research Triangle Park, North Carolina (1986–1987), he conducted retrospective scientific audits of 23 NTP carcinogenicity studies and participated in discussions with the representatives of NTP, FDA, and EPA to review the results of scientific audits of over 200 NTP carcinogenicity studies. In 1987, he joined Ciba-Geigy Pharmaceuticals in New Jersey as Head/Manager of pathologists in preclinical safety and was also responsible for establishing pathology peer review, quality control, and scheduling systems. He continued to work primarily in this position with increasing responsibilities at Ciba-Geigy and then Novartis Pharmaceuticals (after Ciba-Sandoz merger in 1997) to become director and eventually Executive Director and Head of pathology. During this time, he also served as an international project team representative for a number of successfully marketed CNS, immunosuppression, diabetes, and cardiovascular drugs, including Diovan, which eventually became one of the 15 all-time, best-selling prescription drugs. He also held an adjunct academic appointment of Assistant Professor at the University of Medicine and Dentistry, New Jersey, for 8 years. He successfully led several global preclinical safety initiatives at Novartis, including patient centricity, review of best practices in cardiotoxicity and ocular toxicity, as well as evaluation of rodent carcinogenicity potential based on noncarcinogenicity data to minimize future delays in regulatory submissions. Since retirement from Novartis Pharmaceuticals in 2012, Dr Sahota has been the President of Global ToxPath LLC located in Kennewick, WA, USA (Toxicologic Pathology Con