Norah
★    

Tunisia,
2018-03-09 16:48

Posting: # 18515
Views: 1,841
 

 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
★★★
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Vienna, Austria,
2018-03-09 17:44

@ Norah
Posting: # 18516
Views: 1,553
 

 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
nothing

2018-03-09 18:13

@ Helmut
Posting: # 18517
Views: 1,529
 

 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
★    

Tunisia,
2018-03-12 09:37

@ nobody
Posting: # 18522
Views: 1,441
 

 specific guidelines for psychotropic

Yes !! thanks
Norah
★    

Tunisia,
2018-03-12 09:37

@ Helmut
Posting: # 18521
Views: 1,443
 

 specific guidelines for psychotropic

Thank you Helmut !!!


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

Russia,
2018-03-10 08:38

@ Norah
Posting: # 18519
Views: 1,505
 

 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
★    

Tunisia,
2018-03-12 09:38

@ mittyri
Posting: # 18523
Views: 1,422
 

 specific guidelines for psychotropic

Dear Mittyri
Yes it is really helpful !

Thanks


Edit: Please don’t shout[Helmut]
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