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ioanam ★ Romania, 2008-12-10 01:32 (6412 d 08:03 ago) Posting: # 2901 Views: 2,997 |
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Hello The international guidance (ICH, FDA) recommend for the modified release formulation 2 BE studies: single dose and multiple dose (steady state). The sponsor performed only a multiple dose study for a MR product. If the SD and SS PK parameters are the same, do you consider that the study may be approved by a national agency? Have a good day, Jo |
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Helmut ★★★   Vienna, Austria, 2008-12-10 13:38 (6411 d 19:57 ago) @ ioanam Posting: # 2902 Views: 2,636 |
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Dear Jo! ❝ The international guidance (ICH, FDA) recommend for the modified release ❝ formulation 2 BE studies: single dose and multiple dose (steady state).
❝ The sponsor performed only a multiple dose study for a MR product. Hhm. What do you mean by ❝ SD and SS PK parameters are the same' ❝ ... do you consider that the study may be approved by a national agency? Which one? Regulations differ… Edit: Link corrected to latest archived copy. [Helmut] — 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 |
![[image]](img/uploaded/IAsmall.png)
Section III.A.6.|
ioanam ★ Romania, 2008-12-10 15:49 (6411 d 17:47 ago) @ Helmut Posting: # 2904 Views: 2,429 |
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Thank you for your response. I am really sorry, but I was thinking on the EMEA guidance CPMP/EWP/280/96 for the modified release dosage forms. Indeed, in the reference Spc is noted that the product follows linear PK. I don't agree the Sponsor idea to perform only a multiple dose BE study for the MR product, but I really would like to know if there is a rational scientifically explanation in this case. Jo |
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Helmut ★★★ Vienna, Austria, 2008-12-10 20:16 (6411 d 13:19 ago) @ ioanam Posting: # 2905 Views: 2,484 |
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Dear Jo! ❝ [...] I was thinking on the EMEA guidance CPMP/EWP/280/96 for the modified ❝ release dosage forms. Oh, I was confused since you mentioned ICH & FDA.  ❝ Indeed, in the reference Spc is noted that the product follows linear PK. Fine. ❝ I don't agree the Sponsor idea to perform only a multiple dose BE ❝ study for the MR product, but I really would like to know if there is a ❝ rational scientifically explanation in this case. I would not do it either. The only rationale I could think of is the other way 'round, namely performing a single dose study only (e.g., for delayed release formulations, where no accumulation occurs). CPMP/EWP/280/96 in Section 5.1 clearly states: 'Prolonged release formulations can be assessed as bioequivalent on the basis of single and multiple dose studies [...] performance of the test and the reference formulation is equivalent after single dose and at steady state'. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz