Title: PRECLINICAL DEVELOPMENT OF ANTICANCER DRUGS
Name: Dr. B.V.Ravichandra
Cipla Ltd., Mumbai. PIN - 400 083. INDIA
Preclinical cell culture and animal efficacy testing models are currently used to identify, assess, and prioritize chemical agents and natural products with the aim of preventing human cancer. The value of any preclinical model will ultimately depend on its ability to accurately predict clinical response. The entry of new anticancer treatments into phase I clinical trials is ordinarily based on relatively modest preclinical data. Tthe battery of preclinical tests important for assessing safety under an Investigational New Drug application (IND) and outlines a basis for extrapolating starting doses of investigational anticancer drugs in phase I clinical trials from animal toxicity studies. These animal bioassays afford a strategic framework for evaluating agents according to defined criteria, and not only provide evidence of agent efficacy, but also serve to generate valuable dose-response, toxicity, and pharmacokinetic data required prior to Phase I clinical safety testing. Over time, a general transition has been observed from the empirical drug screening of cytotoxic agents against uncharacterized tumor models to the target-orientated drug screening of agents with defined mechanisms of action. Based on preclinical efficacy and toxicity screening studies, only the most successful agents considered to have potential as human chemo-preventives will progress into clinical chemoprevention trials. Key elements are necessary for the ideal animal model for chemoprevention testing: the animal model should bear relevance to human. Factors to consider in the design of preclinical studies of combination therapies, alternative therapies, and adjuvant therapies in the treatment of cancer, and to support changes in clinical formulations or route of administration, will also be discussed.
Biography
Dr. B.V.Ravichandra has completed his DVM (Equivalent to BVSc & AH) at the age of 23 years from Karanataka Veterinary and Animal Sciences University and MVSc postgraduate studies from Madras Veterinary College, Tamilnadu Veterinary and Animal Sciences University, Chennai and he has been awarded Fellow and Associate of Academy of Sciences (Animal Welfare) by Animal Welfare Board, Ministry of Envirnement and Forest, Govt of India. Currently, he is the preclinical ScientistatCipla Ltd, Mumbai, India, a premier Generic Pharma. He has published nearly 10papers in reputed international journals.
Presenting author details
Dr. B.V.Ravichandra
DVM, MVSc (Veterinary Pharmacology and Toxicology), FASC (AW)
Preclinical Scientist
Clinical Research and Development
Cipla Ltd., R & D Centre, 4th floor, North block, LBS road, Vikhroli
Mumbai. PIN - 400 083. INDIA
Contact Numbers: Mobile: +91-7045662775; Work: +91-22-2575 6435.
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Category: (Oral presentation/ Poster presentation)