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Norah ★ Tunisia, 2018-03-09 17:48 (2509 d 21:46 ago) Posting: # 18515 Views: 4,328 |
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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 !! |
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Helmut ★★★   Vienna, Austria, 2018-03-09 18:44 (2509 d 20:50 ago) @ Norah Posting: # 18516 Views: 3,683 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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nobody nothing 2018-03-09 19:13 (2509 d 20:21 ago) @ Helmut Posting: # 18517 Views: 3,618 |
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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 |
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Norah ★ Tunisia, 2018-03-12 10:37 (2507 d 04:57 ago) @ nobody Posting: # 18522 Views: 3,557 |
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Yes !! thanks |
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Norah ★ Tunisia, 2018-03-12 10:37 (2507 d 04:57 ago) @ Helmut Posting: # 18521 Views: 3,557 |
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mittyri ★★ Russia, 2018-03-10 09:38 (2509 d 05:56 ago) @ Norah Posting: # 18519 Views: 3,666 |
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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 |
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Norah ★ Tunisia, 2018-03-12 10:38 (2507 d 04:56 ago) @ mittyri Posting: # 18523 Views: 3,534 |
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Ing. Helmut Schütz