\ue001for new uses of existing drugs,
\ue001new drug delivery systems etc.
\ue001Evidence to prove the efficacy and safety in human beings.
\ue001Only a well designed clinical study on a defined population can give meaningful
100 patients 40-50% 40 patients 50-60% 10 patients 60-70%
There were 10 drop outs due to following reasons
4- no improvement
3 -reasons not known
tingling and numbness
Trial poorly designed No definite outcome, Results ambiguous
Trial well designed, organised and conducted
\ue001Ancient pharmacy practice
\ue001Drugs given on trial and error basis
\ue001Practicing physician decided all.
\ue001Growth of Pharma industry
\ue0011947 Nuremberg code after the trials by the Nazi physicians
\ue001Emphasized on the informed consent
\ue001Drugs and cosmetics act 1940
\ue001Indian GCP guidelines
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