|
|
|
| |
|
SAFETY
& CLINICAL DEVELOPMENT
Clinical & Experimental Medicine |
 |
|
|
Clinical group is involved in conducting
Clinical Trials of candidate drugs developed
at CDRI, Lucknow. This includes undertaking
responsibilities of a Sponsor i.e.
|
| |
|
Preparation
of
Clinical Trial documents (CTD) |
| • |
Plan and Protocol
for Phase I, II and III Clinical
Trials
|
| • |
Case record forms (CRF) |
• |
IND applications |
• |
Clinical study/trial reports |
• |
New drug application (NDA) |
• |
Investigators Brochures (IB) |
• |
Informed consent forms |
• |
Ethics Committee document preparation |
• |
ADR/AE reports |
| |
|
Co-ordination
of Clinical Trials |
| • |
Selection of Clinical Trial Centers/Investigators |
| • |
Conduct/organize Investigator meetings |
• |
Clinical Trial Monitoring |
• |
Setting up to DSMB |
| |
|
Interaction
with Regulatory Agencies |
| • |
Drugs Controller General (India) |
| • |
Institutional Ethics Committees |
• |
Independent Drug Monitoring Committees
(IDMCs) |
| |
|
Interaction
with Pharmaceutical Industries for
|
| • |
Joint Collaboration |
| • |
Commercialization of approved products |
• |
ADR and Pharmacovigilance |
| |
|
Clinical
Trials being multi-Institutional activities,
the Clinical Trial group has been collaborating
with various Institutions/Organizations
for conducting Clinical Trials as per Schedule
“Y” (Drugs and Cosmetics (IInd
Amendment) Rules, 2005) and GCP guidelines.
CDRI has been collaborating with Clinical
Pharmacology Unit at Seth
G.S. Medical College & KEM Hospitals
Mumbai and Clinical
Pharmacology Unit, PGIMER, Chandigarh
for Phase I Clinical Trials of CDRI candidate
drugs. Phase II and III Clinical Trials
involve collaboration with various Medical
Institutions of India like CSM Medical University
(erstwhile K.G’s Medical College),
Lucknow; SGPGI, Lucknow; PGIMER, Chandigarh;
AIIMS, New Delhi; Seth G.S. Medical College,
Mumbai; IMS BHU, Varanasi; Gandhi Medical
College Bhopal; Army Hospital, New Delhi
and Srinagar; SMS Medical College, Jaipur
to name a few. |
| |
| Clinical
group has made major contribution
in the various drugs marketed by CDRI
and presently a number of promising candidate
drugs are in various phases of clinical
developed. |
| |
| Team
members |
|
|
|
| |
| |
|
|
| |
|
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. |
|
|
|
 |
| Powered
by MARG Software Solutions |
Contact
us |
You
are Visitor No. |
| Best viewed
at 800 X 600 Resolutions | Internet
Explorer 5.0 - Later Version |
<%
if session("iNumber")="" then
'conn.open mydsn
Dim rsHits
Set rsHits=Server.CreateObject("ADODB.Recordset")
rsHits.CursorLocation=adUseClient
rsHits.Open "Select visits from Hits", conn, adOpenKeyset, adLockOptimistic
session("iNumber")=rsHits("visits") + 1
rsHits("visits")=rsHits("visits") + 1
rsHits.Update
rsHits.Close
set rsHits=Nothing
end if
If Len(session("iNumber")) > 0 then
'Display iNumber
Response.Write "" & ConstructDigits(session("iNumber")) & ""
End If
''''
Function ConstructDigits(iValue)
'This function accepts a single parameter, iValue, and
'returns HTML containing a series of images representing
'a graphical image of the value in iValue
'Start by ensuring iValue is a number
If Not IsNumeric(iValue) then
ConstructDigits = iValue & " IS NOT A NUMBER!"
Exit Function
End If
'Can't show decimals!
If InStr(1, iValue, ".") then
ConstructDigits = "CANNOT CONTAIN DECIMALS!"
Exit Function
End If
'Can't show negative numbers!
If iValue < 0 then
ConstructDigits = "CANNOT DISPLAY NEGATIVE NUMBERS!"
Exit Function
End If
Dim iLoop, strResults
For iLoop = (Len(iValue) - 1) to 0 STEP -1
strResults = strResults & ""
Next
ConstructDigits = strResults
End Function
''''
%>
|
|
|
|
|
|
