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| CLINICAL
TRIALS |
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OBJECTIVE
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undertake clinical trials
of the Institutes candidate drugs.
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| SCIENTISTS
ASSOCIATED WITH THE PROJECT |
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| FACILITIES
AVAILABLE |
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Protocol development
for phase I to phase IV clinical trials
and human pharmacokinetic studies. |
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Capabilities
to undertake phase I clinical trials
in healthy human volunteers. |
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Effective
coordination and management of phase
II & III clinical trials for efficacy
evaluation in specified patient population.
(CPU, KGMC, Lucknow and Seth G.S. Medical
College, Bombay are two extension units
of the department providing valuable
support for phase II and III clinical
trials. |
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Infrastructure
available for phase I, II & III
data recording, retrieval and statistical
analysis. |
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Phase IV post
marketing surveillance for ADR monitoring
and drugs surveillance in close coordination
with pharmaceutical industry and Drugs
Controller General of India. |
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Capabilities
to formulate clinical trial reports,
dossiers on new investigational drugs
for submission to Drugs Controller General
(India) for clinical trial (phase I
to phase IV) and marketing permission. |
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Essential
requirement for undertaking clinical
trials available in the Department |
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Facilities
for physical examination of volunteers/patients,
laboratory investigations: Haematology,
Clinical Biochemistry, Complete Urinalysis,
Stool Examination, Platelet Aggregation
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website
copyright © 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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