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Vishal S ☆ India, 2021-05-24 11:21 (1228 d 10:05 ago) Posting: # 22363 Views: 2,989 |
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How to prove the bioequivalence if test formulation having strength 325 mg and reference formulation having strength 500 mg Edit: Category changed; see also this post #1. Please follow the Forum’s Policy. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2021-05-24 14:32 (1228 d 06:55 ago) @ Vishal S Posting: # 22364 Views: 2,452 |
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Hi Vishal, ❝ How to prove the bioequivalence if test formulation having strength 325 mg and reference formulation having strength 500 mg When administering single doses, such a large dose-correction will not be acceptable (see there). I did it once 20 years ago when strict dose-proportionality was known for R and proven for T in another study. It was accepted by the German BfArM but we were told at the same time “Please do that never again.” You would need to administer the least common multiple of the strengths (6,500 mg), i.e., 20 units of T and 13 units of R. This will be difficult even if this single dose is within the approved range. — 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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Vishal S ☆ India, 2021-05-25 15:26 (1227 d 06:01 ago) @ Helmut Posting: # 22365 Views: 2,339 |
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Hii Helmut Thank you for replay we are designing the fixed dose combination Immediate release test formulation(A+B) having strength 100 mg (A) and 325 mg (B), RLD for FDC formulation not approved in EU market & not available so we are using two different RLDs ie RLD (A) of 100 mg strength and RLD (B) having 500 mg strength. Note than RLD (B) available in EU market in 500 mg strength, 325 mg strength not available as RLD. please guide me for BE study for same Thanks and Regards Vishal S Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe] |
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drgunasakaran1 ★★  2021-05-25 16:22 (1227 d 05:05 ago) @ Vishal S Posting: # 22366 Views: 2,317 |
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Dear Mr Vishal, ❝ we are designing the fixed dose combination Immediate release test formulation(A+B) having strength 100 mg (A) and 325 mg(B), RLD for FDC formulation not approved in EU market & not available so we are using two different RLDs ie RLD (A) of 100 mg strength and RLD (B) having 500 mg strength. Note than RLD (B) available in EU market in 500 mg strength, 325 mg strength not available as RLD. If possible, can we know the name of molecules to understand the rationale of individual strengths in the proposed FDC and to assess the clinical advantages of proposed FDC against the use on monotherpies. Is it Aceclofenac/Paracetamol 100/325 mg FDC formulation?? — Dr S Gunasakaran MBBS MD Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same. |
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Helmut ★★★ Vienna, Austria, 2021-05-26 02:23 (1226 d 19:04 ago) @ Vishal S Posting: # 22367 Views: 2,251 |
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Hi Vishal, ❝ we are designing the fixed dose combination Immediate release test formulation(A+B) […] 325 mg(B) […] Note than RLD (B) available in EU market in 500 mg strength, 325 mg strength not available as RLD.
— 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