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drmuneesh ★ 2009-03-31 13:04 (6292 d 21:09 ago) Posting: # 3422 Views: 4,981 |
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Dear All I am planning a BE study of Bicalutamide 150 mg tablet. The two (R) & (S) - enantiomers of Bicalutamide have different pharmacokinetics. Tmax of active (R)- enantiomer is 15-48 hr and that of inactive (S)- enantiomer is 2-5 hr. T1/2 of active (R)- enantiomer is about 1 week and that of (S)- enantiomer is 19 hr. The study has been planned with the parallel truncated design upto 72 hrs and time points for blood sample collection are 0.00, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 12.00, 14.00, 15.00, 16.00, 18.00, 24.00, 28.00, 32.00, 36.00, 40.00, 44.00, 46.00, 48.00, 50.00, 60.00 and 72.00. Please suggest:
Regards Dr Muneesh Garg |
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MGR ★ India, 2009-04-01 10:18 (6291 d 23:55 ago) @ drmuneesh Posting: # 3429 Views: 3,924 |
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Dear Dr.Muneesh Garg, The following link may help you regarding the Design etc., USFDA Recommendation on Bicalutamide And we have done the study on Healthy volunteers with an 50 mg dose for USFDA submission with 60 subjects and it passed both Fasting and Fed conditions. Thank you, — Regards, MGR |
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drmuneesh ★ 2009-04-02 13:10 (6290 d 21:03 ago) @ MGR Posting: # 3452 Views: 3,858 |
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Dear MGR Thank you for the guidance. Can you please suggest the time points and safety of 150 mg dose in healthy human subjects. Regards Dr Muneesh Garg |
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martin ★★ Austria, 2009-04-03 10:45 (6289 d 23:29 ago) @ drmuneesh Posting: # 3453 Views: 3,789 |
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dear drmuneesh ! selection of time points is discussed for example in this thread. hope this helps martin |
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drmuneesh ★ 2009-04-03 11:42 (6289 d 22:32 ago) @ martin Posting: # 3454 Views: 3,708 |
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Dear Martin Thank you for the guidance. But in this case Tmax of active (R)- enantiomer is 15-48 hr and that of inactive (S)- enantiomer is 2-5 hr. Should I consider the Tmax of both the (R) & (S) - enantiomers of Bicalutamide for deciding time points or only the active(R)- enantiomer which we are analyzing. Also the Tmax range of 15-48 hr is quite wide. In this case how to decide the time points so as not to miss the real Cmax. Please suggest. Dr Muneesh Garg |
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martin ★★ Austria, 2009-04-04 21:40 (6288 d 12:34 ago) @ drmuneesh Posting: # 3466 Views: 3,770 |
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dear drmuneesh ! you are really planning a BE study when you know that the reference and test treatment have different pharmacokinetics (i.e. different shapes of the concentrations versus time curve) ? martin |
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Ohlbe ★★★ France, 2009-04-05 01:38 (6288 d 08:36 ago) @ martin Posting: # 3469 Views: 3,686 |
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Dear Martin, Both the reference and the test product contain racemic bicalutamide. The question is then how to plan the sampling times, keeping in mind that the two enantiomers have different PK characteristics. Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz