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SAFETY
& CLINICAL DEVELOPMENT
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Safety, Dosage Form Design, Pre-Clinical
and Clinical Development of candidate
drugs
are the primary concerns
of the Divisions of
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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: |
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| Team
members |
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| Pharmaceutics |
Safety Pharmacology
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Toxicology |
| Dr.AK
Dwivedi |
Dr
M Dikshit |
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Dr
S. Sharma |
| Dr.
Amit Misra |
Dr
R Shukla |
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Dr
SK Rath |
| Dr.PR
Mishra |
Dr
M Bharatwal |
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Dr
RK Tripathi |
| Dr.MK
Chourasia |
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Dr
RK Singh |
| Pharmacokinetics |
Clinical & Experimental Medicine |
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Dr
A Nazir |
| Dr.
J Lal |
Dr.A
Ghatak |
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Dr
Smrati Bhadauria |
| Dr
Wahajuddin |
Dr.Vivek
Bhosale |
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Dr
Sarika Singh |
| Dr
RS Bhatta |
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Dr
Poonam Singh |
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website
copyright © Central Drug Research Institute.
All rights reserved. copy; Central Drug Research Institute.
All rights reserved.
No part of this should be Downloaded or used
in any way other than the non-commercial purposes
without prior permission of the Director,
CDRI. |
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