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pravin17 ★ India, 2016-05-03 10:07 (3245 d 11:54 ago) Posting: # 16263 Views: 10,133 |
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Dear All, Test product is extended release tablet compered with reference product which is immediate release tablet, my question is whether this study is bio availability study or bio equivalence study? Thank You in Advance Pravin Edit: Category changed; see also this post #1. [Helmut] |
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Ohlbe ★★★ France, 2016-05-03 12:25 (3245 d 09:36 ago) @ pravin17 Posting: # 16264 Views: 8,801 |
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Dear Pravin, What is your opinion ? Do you think an extended release formulation can be bioequivalent to an immediate release fomulation ? — Regards Ohlbe |
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jag009 ★★★ NJ, 2016-05-10 01:09 (3238 d 20:52 ago) @ Ohlbe Posting: # 16285 Views: 8,449 |
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Hi Ohlbe ❝ Do you think an extended release formulation can be bioequivalent to an immediate release fomulation ? It is possible if he is talking about a ER q.d. vs IR b.i.d (or t.i.d, or q.i.d.) formulation under the same total daily dose where in some cases one might want to demonstrate bioquivalence between the two products. Example, Ultram ER is bioequivalent to Tramadol IR (given as qid).... John |
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Helmut ★★★   Vienna, Austria, 2016-05-10 18:08 (3238 d 03:53 ago) @ jag009 Posting: # 16287 Views: 8,431 |
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Hi John & Ohlbe, ❝ It is possible if he is talking about a ER q.d. vs IR b.i.d (or t.i.d, or q.i.d.) formulation under the same total daily dose where in some cases one might want to demonstrate bioquivalence between the two products. Example, Ultram ER is bioequivalent to Tramadol IR (given as qid).... ![[image]](img/uploaded/image358.png) CFR 21(5) §320.1 (a) Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. Already this definition sends pharmacokineticists through the ceiling. According to the book, BA means only the AUC (strictly speaking the AUC0–∞ or AUC0–τ). There is no “rate of BA” in PK. (e) Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain extended release dosage forms), certain pharmaceutical equivalents or alternatives may be considered bioequivalent if there is no significant difference in the extent to which the active ingredient or moiety from each product becomes available at the site of drug action. This applies only if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and is reflected in the proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug. So, given the blue part, John is right.— 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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Ohlbe ★★★ France, 2016-05-11 00:03 (3237 d 21:58 ago) @ Helmut Posting: # 16289 Views: 8,321 |
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Dear Helmut and John, ❝ So, given the blue part, John is right. On a purely US, regulatory, non-PK point of view, yes — Regards Ohlbe |
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nobody nothing 2016-05-03 12:41 (3245 d 09:20 ago) @ pravin17 Posting: # 16265 Views: 8,821 |
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Hi Pravin! ...if you try the latter and nobody in your organization stops you, at least the ethics board should have substantial objections — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2016-05-03 13:55 (3245 d 08:06 ago) @ pravin17 Posting: # 16267 Views: 8,954 |
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Hi Pravin, I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR. Homework: Why does he do so? Bonus question: Why is he right? — 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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nobody nothing 2016-05-03 16:07 (3245 d 05:54 ago) @ Helmut Posting: # 16269 Views: 8,842 |
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❝ I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR. Guy with "comparative bioavailability" hobby?  — Kindest regards, nobody |
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d_labes ★★★ Berlin, Germany, 2016-05-03 17:50 (3245 d 04:11 ago) @ Helmut Posting: # 16272 Views: 8,788 |
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Hi Helmut, ❝ I know one European assessor who rejects protocols containing the word bioequivalence in its title. Yes, even if it is a study of IR vs. IR. ❝ ❝ Homework: Why does he do so? To be not bounded by an document called "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" in his assessment? — Regards, Detlew |
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Helmut ★★★ Vienna, Austria, 2016-05-03 19:44 (3245 d 02:17 ago) @ d_labes Posting: # 16274 Views: 8,912 |
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Dear Detlew, ❝ To be not bounded by an document called "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" in his assessment? Nope. The guess of nobody above was correct. Let me highlight the relevant part: "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result). The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?” — 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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d_labes ★★★ Berlin, Germany, 2016-05-04 10:43 (3244 d 11:18 ago) @ Helmut Posting: # 16279 Views: 8,677 |
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Dear Helmut, ❝ We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result). Up to now my understanding of a bioavailability study was: A study with the aim to study the extent of availability in the body, without the aim to show equivalence. F.i. intra-venious application versus oral. ❝ The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?” IMHO this is a very sophisticated and nitpicking attitude, suitable to wow NLYW .In the same spirit you can't speak about non-inferiority or superiority studies. But: "Jedem Tierchen sein Pläsierchen" (rough translation "To each their own"). Especially if it (the beastie) is an assessor. — Regards, Detlew |
Ing. Helmut Schütz