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SAFETY & CLINICAL DEVELOPMENT

Safety, Dosage Form Design, Pre-Clinical and Clinical Development of candidate drugs
are the primary concerns of the Divisions of

 
Together, these divisions represent the “CRO” (committed research organization)-- available to drug discovery scientists at CDRI and collaborating research organization for other academic or industry partners in drug development. Task forces formed by designated personnel from these Divisions are entrusted with the development of new chemical entities / new drug entities. Investigational New Drug (IND) applications are prepared as per guidelines of Schedule Y of the Indian Drugs & Cosmetics Act, (Amended 2005). The group is involved in generation of a large amount of data in relation to methods of manufacture and resultant analytical specifications, storage stability, formulation and delivery systems, pharmacokinetics, pharmacological mechanisms of action, efficacy and safety in animal models including rodents and non-human primates and the elucidation of mechanisms responsible for different pharmacological and toxicological effects. Based on such data, necessary documents and protocols are prepared for seeking regulatory permission and conduction of clinical trials. The following activities are carried out in cohesion by the constituent Divisions:
 
 
 
Team members
..

Area Coordinator
Asst Coordinator
.............. Dr C. Nath
................Dr Amit Misra
...............Dr A.K.Diwedi (Pharmaceutics)
...............Dr G.K.Jain (Pharmacokinetics)
..... .........Dr Ram Raghubir (Safety Pharmacology)
...............Dr C. Nath (Regulatory Toxicology)
...............Dr S.P.S. Gaur (Clinical Trials)
 
Pharmaceurics Safety Pharmacology
  Toxicology
Dr.AK Dwivedi Dr.R Raghubir   Dr. C Nath
Dr. Amit Misra Dr M Dikshit   Dr. N Sinha
Dr.PR Mishra Dr R Shukla   Dr S. Sharma
Dr.MK Chourasia Dr M Bharatwal   Dr SK Rath
Pharmacokinetics Clinical & Experimental Medicine   Dr RK Tripathi
Dr G K Jain Dr SPS Gaur   Dr RK Singh
Dr S K Singh Dr.J.S. Srivastava   Dr A Nazir
Dr. J Lal Dr.A Ghatak   Dr Smrati Bhadauria
Dr Wahajuddin     Dr Sarika Singh
Dr RS Bhatta     Dr P Singh
 
 
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