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Jasmin ● 2007-07-25 11:01 (6914 d 05:31 ago) Posting: # 933 Views: 7,608 |
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Dear HS, The pharmacodynamic BE study and Clinical end point BE study, both study are same or not. if not, what is the difference between both study? what is the suitable study design for above study? with best regards Jasmin |
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Jaime_R ★★ Barcelona, 2007-07-25 16:20 (6914 d 00:11 ago) @ Jasmin Posting: # 939 Views: 6,556 |
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Dear Jasmin, although I'm not Helmut (1350 km SE of Vienna), I dare answering as well.  ❝ The pharmacodynamic BE study and Clinical end point BE study, both study ❝ are same or not. No, they aren't. ❝ if not, what is the difference between both study? See this thread, and this post as well. A nice example are statins: the pharmacodynamic effect(s) are lipid-lowering (decrease in chloesterol, LDL, triglycerides, increase in HDL), whereas the clinical endpoints are based on survival rates (heart attack, stroke, peripheral vascular disease). ❝ what is the suitable study design for above study? Generally parallel groups of patients; main difference is the samples size. For the statin-example a PD study would need dozens to hundreds of patients, whereas a study based on clinical equivalence would need many, many thousands (since the efficacy/safety studies of verum vs. placebo already needed such a high number). On the other hand, if the desease is chronic and stable (like asthma), a washout reestablishing the orginal state, even a cross-over study in less than 50 patients may be considered. — Regards, Jaime |
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Jasmin ● 2007-07-31 10:07 (6908 d 06:24 ago) @ Jaime_R Posting: # 944 Views: 6,457 |
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Dear Sir, Thanks for solving my confusion. I understood the difference between Clinical end point study and pharmacodynamic study. kindly solve one more query. which condition any regulatory wants Clinical end point study? is there any specific criteria or product category in Clinical end point study? with best regards Jasmin |
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Jaime_R ★★ Barcelona, 2007-07-31 16:52 (6907 d 23:40 ago) @ Jasmin Posting: # 949 Views: 6,389 |
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Dear Jasmin! ❝ Dear Sir... ❝ which condition any regulatory wants Clinical end point study? Generally it's a double blind three-armed parallel study (Test-Reference-Placebo) in a patient population according to the labeled dosing of the reference; trial design and endpoints should be similar to the NDA. You will need the placebo arm to validate the study. For details see this presentation. ❝ is there any specific criteria or product category in Clinical end point ❝ study? According to my knowledge a clinical endpoints BE study is the 'last retreat' - where everything else fails, i.e., conventional BE or a BE study based on pharmacodynamic (surrogate) endpoints. — Regards, Jaime |
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Jasmin ● 2007-08-01 09:26 (6907 d 07:05 ago) @ Jaime_R Posting: # 952 Views: 6,404 |
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Dear jaime Thanks for improving my knowledge |
Ing. Helmut Schütz