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RegisterPassing SD and Failing MD [General Statistics]
posted by Helmut 
– Vienna, Austria, 2013-11-29 18:29 (4173 d 11:55 ago) – Posting: # 11990
Views: 14,524
Hi Luv,
That’s an interesting story! Were the PEs in the MD study shifted to the same direction (i.e., were in MD the ratios also <100%)? How did the CVs “behave”?
The only case I know from the literature is quite old.* The authors were disappointed that the CVs did not substantially decrease in MD (at that time MD was an accepted method to assess BE of HVDPs). On the other hand their single dose studies were amazingly small (n=4 and n=5)…
❝ We have done a couple of studies for a molecule (BCS class II molecule, solubility lesser at higher pH, almost insoluble at pH 6 and above, MR pellets) .
❝
❝ In MD, product failed in Cmin ss and AUCTss.
That’s an interesting story! Were the PEs in the MD study shifted to the same direction (i.e., were in MD the ratios also <100%)? How did the CVs “behave”?
The only case I know from the literature is quite old.* The authors were disappointed that the CVs did not substantially decrease in MD (at that time MD was an accepted method to assess BE of HVDPs). On the other hand their single dose studies were amazingly small (n=4 and n=5)…
- Van Hoogdalem EJ, Terpstra IJ, Krauwinkel WJJ, Volkers-Kamermans NJ, Baven, ALM, Verschoor JSC. Multiple dose bioequivalence study with josamycin propionate, a drug with highly variable kinetics, in healthy volunteers. Int J Clin Pharmacol Ther. 1996;34(5):202–7.
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Ing. Helmut Schütz