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Back to the forum  2018-07-23 00:42 CEST (UTC+2h)
Norah
Junior

Tunisia,
2018-03-09 16:48

Posting: # 18515
Views: 856
 

 specific guidelines for psychotropic [Regulatives / Guidelines]

Dear all, is there any specific recommendation for BE studies concerning psychotropic ? for exmple for quetiapine should we use the less existing dose (for safety reasons) or we can use the higher dose ?? thanks !!
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-03-09 17:44

@ Norah
Posting: # 18516
Views: 738
 

 specific guidelines for psychotropic

Hi Norah,

» […] is there any specific recommendation for BE studies concerning psychotropic ?

None that I recall.

» […] for quetiapine should we use the less existing dose (for safety reasons) or we can use the higher dose ??

The FDA recommends three studies: Single dose 25 mg fasting and fed in healthy subjects and 300 mg steady state in schizophrenic patients already receiving quetiapine in a stable regimen.

Whether studies in healthy subjects are possible at all depends on the local legislation. F.i., in China studies of narcotics are prohibited. However, such studies are possible in Hong Kong (doublethink?)… In other countries the procedure is burdensome. In India (once the protocol was accepted by the DCGI and IEC) you have to submit the entire stuff to the Central Bureau of Narcotics (which is notoriously slow).

Furthermore, in many countries handling of narcotic drugs (as IMPs in studies) is regulated in the respective National Medicines Laws and/or Bylaws depending on the Schedule of the drug. This includes procedures for restricted access to storage areas, resistance classes of safes, etc.

Cheers,
Helmut Schütz
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nobody
Senior

2018-03-09 18:13

@ Helmut
Posting: # 18517
Views: 727
 

 specific guidelines for psychotropic

the example chosen here, quetiapine, is an antipsychotic. Not scheduled in any way. But for sure safety concerns in healthy volunteers depending on dose.

I would have a look at the targeted jurisdiction and if in doubt, bail out. As for advice... ;-)

Kindest regards, nobody
Norah
Junior

Tunisia,
2018-03-12 09:37

@ nobody
Posting: # 18522
Views: 610
 

 specific guidelines for psychotropic

Yes !! thanks
Norah
Junior

Tunisia,
2018-03-12 09:37

@ Helmut
Posting: # 18521
Views: 614
 

 specific guidelines for psychotropic

Thank you Helmut !!!


Edit: Please don’t shout[Helmut]
mittyri
Senior

Russia,
2018-03-10 08:38

@ Norah
Posting: # 18519
Views: 697
 

 specific guidelines for psychotropic

Dear Norah,

» is there any specific recommendation for BE studies concerning psychotropic ? for exmple for quetiapine should we use the less existing dose (for safety reasons) or we can use the higher dose ??

Did you get a chance to look into EMA PKWP Q&A?
There are some useful sentences regarding Quetiapine XR in section 14


Edit: Document linked. [Helmut]

Kind regards,
Mittyri
Norah
Junior

Tunisia,
2018-03-12 09:38

@ mittyri
Posting: # 18523
Views: 616
 

 specific guidelines for psychotropic

Dear Mittyri
Yes it is really helpful !

Thanks


Edit: Please don’t shout[Helmut]
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