Back to the Top
dear sir,
i have query regarding B.A./B.E. study of specific category drug
sir, if we are going to market a drug for specific indication in
specific gender i,e. female then do we need to conduct bio study on
female volunteers only.
for eg. one drug which is going to be marketed for treatment of female
patient only then can we conduct bio study on male patient , that drug
is also been taken by male patient for another indication by different
route.
kindly reply me the same
Regards,
Gaurav
Back to the Top
dear friend , if the drug is only being used for female patient then
you should study it on female patients because there are lot of
differences in metabolism of female and male.for tratig any
gyenecological disorders if you are studying the drug then it will be
meaningless to use it on male patients.for the study of another
indication on male you can use male patients respectively. so it
matters for which indication you are going to use the drug n then
select gender accordingly.
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "BE study for drug used for female patient" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)