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Rahul ☆ India, 2008-12-24 07:11 (6391 d 20:11 ago) Posting: # 2968 Views: 6,814 |
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Dear members, I am working on Risperidone 1 mg orally desintegrating tablet. The lable claim indicate:- 1. Tmax: Risperidone- 1 hr. 9-OH Risperidone- 3 hrs. in Extensive metabolizers & 17 hrs. in poor metabolizers. 2. Apperent T1/2: Risperidone- 3 hrs. in Extensive metabolizers & 20 hrs. in poor metabolizers. 9-OH Risperidone- 21 hrs. in Extensive metabolizers & 30 hrs. in poor metabolizers. 3. Steady State conc.: Risperidone- 1 day in Extensive metabolizers & 5 days in poor metabolizers. 9-OH Risperidone- 5-6 days in Extensive metabolizers So, I want to ask that, while designing protocol for 2-way cross-over study, what in the significance of Extensive & poor metabolizers? For calculating total sampling Hrs. and wash-out period, is it nessary to consider poor metabilizers effect? So kindly guide me regarding the same... Thanks n Regards, Rahul... — Thanks n regards, Rahul... |
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raghu ★ India, 2008-12-24 14:00 (6391 d 13:22 ago) @ Rahul Posting: # 2974 Views: 5,726 |
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Dear Rahul Risperidone metabolised by CYP 2D6 enzyme. It is (CYP 2D6) present in the Caucasians very little that is 6-8% refer 4 th page of http://www.fda.gov/cder/foi/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf Better on the safer side you have to consider the both poor and extensive metabolisers Regards Raghu |
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ElMaestro ★★★ Denmark, 2008-12-25 08:41 (6390 d 18:41 ago) @ raghu Posting: # 2977 Views: 5,772 |
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Since you are comparing fomulations and not metabolisms, I think it would be acceptable (in a purely scientific manner) to simply write in the protocol that poor metabolisers are excluded; this involves testing for it at the time of recruitment. Then it becomes easier to time the blood sampling and shorten the study/period duration. EM. |
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kvgreddy06 ☆ India, 2014-04-23 11:19 (4445 d 17:03 ago) @ ElMaestro Posting: # 12874 Views: 4,427 |
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Dear All, Assessment of BE Criteria for risperidone 1mg/1ml oral solution? as per FDA OGD guidelines analytes to be measure is only risperidone in plasma and 90 % CI for Risperidone. But Risperidone has its active metabolite 9-hydroxyrisperidone, my query is for Health canada submission, analytes to be measure both or only parent required? and 90 % CI for ? kindly share your experience with this molecule. Regards. kvgreddy |
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Helmut ★★★   Vienna, Austria, 2008-12-25 14:44 (6390 d 12:38 ago) @ Rahul Posting: # 2979 Views: 5,770 |
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Dear Rahul, I agree with ElMaestro. Phenotyping can be done in screening by administering debrisoquine; an alternative is genotyping (poor metabolizers carrying at least one of the CYP2D6*9, CYP2D6*10, or CYP2D6*17 alleles). For details see Wikipedia. — 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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