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Sorry to interrupt all of you,

but as we will discuss about clinical trial with new drug entities

which is sponsored by out side of our country they have to complete

phase-I study in the respective country , but there is various factor

like genetic, Idiosyncrasy , geographical etc which is ignored by regulatory

authority

which leads to serious events, still we have to carry again phase-1

study in India but if these factor affect the study it leads to

serious unexpected events even in phase-1.

In India there is no any unit have the facility to carry out

micro-dosing (Phase-0) study which minimize the genetical or rashes

difference and give us complete scenario of drug and its

pharmacokinetic.

These types of events not happen in future so we have

to consider all factors.

-- Regard Pushpraj K. Singh(M.Pharm, Pharmacology)

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Dear Singh,

Thanks for the information, but we should talk/discuss on/the current topic (Mother and Child Mortality & Morbidity in Afghanistan).

Best Regards

Mohammad Bashaar

From: pushpraj singh <pushpharma786@...>Subject: Times of Indianetrum Date: Thursday, August 21, 2008, 1:18 PM

Sorry to interrupt all of you,but as we will discuss about clinical trial with new drug entitieswhich is sponsored by out side of our country they have to completephase-I study in the respective country , but there is various factorlike genetic, Idiosyncrasy , geographical etc which is ignored by regulatory authoritywhich leads to serious events, still we have to carry again phase-1study in India but if these factor affect the study it leads toserious unexpected events even in phase-1.In India there is no any unit have the facility to carry outmicro-dosing (Phase-0) study which minimize the genetical or rashesdifference and give us complete scenario of drug and itspharmacokinetic.These types of events not happen in future so we have to consider all factors.-- RegardPushpraj K. Singh(M.Pharm,

Pharmacology)

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I AM INDEED PAINED TO SEE THE FREQUENT INTERUPTIONS DURING THE DISCUSSIONS AND FEEL IMPOTENT TO CONTROL THE SAME.

IF THE MEMBERS DO NOT COOPERATE WE WILL BE FORCED TO CHANGE THE AVAILABILITY OF THIS PLATFORM FROM FREE AND OPEN FORMAT TO EDITED POSTS.

PLEASE DESIST FROM DEVIATIONS DURING THE DISCUSSION.

DR VIJAY THAWANI

GROUP OWNER, NETRUM

>> Sorry to interrupt all of you,> > but as we will discuss about clinical trial with new drug entities> which is sponsored by out side of our country they have to complete> phase-I study in the respective country , but there is various factor> like genetic, Idiosyncrasy , geographical etc which is ignored by regulatory> authority> which leads to serious events, still we have to carry again phase-1> study in India but if these factor affect the study it leads to> serious unexpected events even in phase-1.> > In India there is no any unit have the facility to carry out> micro-dosing (Phase-0) study which minimize the genetical or rashes> difference and give us complete scenario of drug and its> pharmacokinetic.> These types of events not happen in future so we have to consider all> factors.> > > > -- > Regard> Pushpraj K. Singh> (M.Pharm, Pharmacology)>

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