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rohitkachhadiya ☆ Gujarat, 2011-03-21 11:29 (5579 d 22:01 ago) Posting: # 6782 Views: 4,291 |
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Dear All, I have a doubt in Guidance on MR oral and transdermal dosage form, Page 11 of 11, i.e for MR formulations essential similar to Marketed one flow chart. It says that if there is pronounce food effect/no data available then we have to perform both fast and fed study, But if there is no food effect then do fed study only. Is it not something confusing??? Regards RK |
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Helmut ★★★   Vienna, Austria, 2011-03-21 14:34 (5579 d 18:56 ago) @ rohitkachhadiya Posting: # 6787 Views: 3,560 |
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Dear Rohit! ❝ It says that if there is pronounce food effect/no data available then we have to perform both fast and fed study, But if there is no food effect then do fed study only. ❝ ❝ Is it not something confusing??? Why? I guess you are only concerned about the latter. If there is no food effect you have to challenge the new formulation. The worst case scenario is after a high-calory high-fat meal. — 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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rohitkachhadiya ☆ Gujarat, 2011-03-23 07:07 (5578 d 02:23 ago) @ Helmut Posting: # 6795 Views: 3,448 |
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Dear HS, Thanks for response. ❝ Why? I guess you are only concerned about the latter. If there is no food effect you have to challenge the new formulation. The worst case scenario is after a high-calory high-fat meal. Yes. Is it not necessary to conduct Fasting study also?? If there is no food effect then it is better to do fasting study. |
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Helmut ★★★ Vienna, Austria, 2011-03-23 16:26 (5577 d 17:04 ago) @ rohitkachhadiya Posting: # 6797 Views: 3,412 |
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Dear Rohit! ❝ ❝ If there is no food effect you have to challenge the new formulation. The worst case scenario is after a high-calory high-fat meal. ❝ ❝ Is it not necessary to conduct Fasting study also?? If there is no food effect then it is better to do fasting study.
Modified release formulation essentially similar to a marketed form → — 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 |
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rohitkachhadiya ☆ Gujarat, 2011-03-24 06:27 (5577 d 03:03 ago) @ Helmut Posting: # 6800 Views: 3,499 |
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Dear Hs, ❝ Please read my statement above again and consider following the MR-NfG, Appendix 1: ❝ Appendix-1 is the same in which I have query, you can see my first statement ❝ Data from literature indicating no food effect → If literature indicate there is no food effct then why to go for fed study?? ❝ Single dose, 2-way crossover study; ❝ Treatment1: test formulation administered after a high fat meal ❝ Treatment2: reference formulation administered after a high fat meal |
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Helmut ★★★ Vienna, Austria, 2011-03-24 06:45 (5577 d 02:45 ago) @ rohitkachhadiya Posting: # 6801 Views: 3,408 |
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Dear Rohit! ❝ Appendix-1 is the same in which I have query, you can see my first statement I know; I suggested you to read it again.  ❝ If literature indicate there is no food effct then why to go for fed study?? Please read my previous post again. Rationale of the NfG:
— 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 |
) No data of your formulation are available yet.|
Jaime_R ★★ Barcelona, 2011-03-24 13:36 (5576 d 19:54 ago) @ Helmut Posting: # 6804 Views: 3,556 |
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— Regards, Jaime |
Ing. Helmut Schütz