Tamoxifen citrate is not a hormone but an (antiestrogen) estrogen receptor modifier,
Does it need a separate facility like hormones or OK to do cleaning validation?
Greetings ;
I think that cleaning validation / factory specific manufacturing is not a matter of therapeutic class but a matter of the activity of the ingredient to be cleaned.
Pharmacologically speaking, the activity of any agent is to be measure by the ED50 (Effective dose 50
), which directly reflects the effect of high or low doses of the agent.
So, as a start, you should compare the ED50 of Tamoxifen (which is like 0.1 mg/kg) with ED50 of another hormone or hormone like drug (Such as involved in contraceptives), if they are near and if not requiring another facility, the cleaning of Tamoxifen should be at least as more efficient as the cleaning for such hormone.
Regarding this study
, tamoxifene is more likely as active as hormones, so it should be considered carefully
Best Regards
THANK YOU FOR YOUR REPLY.
There is no need in my opinion to make a separate dedicated facility for production of Tamoxifene in the FDA Guidance for industry, please correct me with a list of there is one for active ingredients that need isolated facility to comply with cGMP
Greetings, please my dear colleagues this is urgently needed question:
Is there an FDA, EMEA or WHO list for drugs that must have a dedicated facility?
(Which hormones, and which anticancer)?