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Elena777 ☆ Belarus, 2019-03-13 18:17 (2203 d 20:05 ago) Posting: # 20022 Views: 5,403 |
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Dear all! Please share any idea with me. Chloropyramine is an antiallergic drug. We need to conduct BE study with our chloropyramine tablet vs reference Suprastin. But I failed to find any useful data about pharmacokinetics as well as BE reports of other companies and PARs about drugs with such API. My colleagues failed as well. So we have NO information about CVintra and CI for Cmax and AUCt. And we are not able even to suggest anything. There is nothing to rely on in estimation of sample size. Any help will be highly appreciated! |
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Helmut ★★★   Vienna, Austria, 2019-03-13 19:08 (2203 d 19:14 ago) @ Elena777 Posting: # 20024 Views: 4,521 |
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Hi Elena, ❝ […] Chloropyramine […] I failed to find any useful data about pharmacokinetics as well as BE reports of other companies and PARs about drugs with such API. My colleagues failed as well. You are not alone. What speaks against a pilot study? — 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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Elena777 ☆ Belarus, 2019-03-13 19:55 (2203 d 18:27 ago) @ Helmut Posting: # 20028 Views: 4,629 |
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❝ What speaks against a pilot study? Unfortunately, it's not a common practice in our country (Belarus). If not a pilot study what are other options? Sequential (if yes, how to implement it)? The usual 2X2 design with arbitrary, say a bit more than 30 subjects, sample size? Any other reasonable approaches? 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! [Ohlbe] |
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mittyri ★★ Russia, 2019-03-14 00:06 (2203 d 14:16 ago) @ Elena777 Posting: # 20032 Views: 4,576 |
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Hi Elena, you are right, there's no open data regarding Chloropyramine. By the way GRLS says that at least 2 companies performed BEQ studies. The sample size was (unfortunately we don't know exactly what 'the number of patients' means - sample size? number of subjects intended to be screened?) not more than 22 and 40. I would say this is not HVD. — Kind regards, Mittyri |
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Ohlbe ★★★ France, 2019-03-14 01:08 (2203 d 13:14 ago) @ mittyri Posting: # 20033 Views: 4,504 |
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Dear Mittyri, ❝ By the way GRLS says that at least 2 companies performed BEQ studies. The sample size was (unfortunately we don't know exactly what 'the number of patients' means - sample size? number of subjects intended to be screened?) not more than 22 and 40. I would say this is not HVD. Well, it depends... Does it say whether this sample size was sufficient to conclude ? Maybe they tried their luck (as considered by Elena) and failed with a 90 % CI of 34 - 192 %  — Regards Ohlbe |
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mittyri ★★ Russia, 2019-03-14 12:28 (2203 d 01:54 ago) @ Ohlbe Posting: # 20034 Views: 4,546 |
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Dear Ohlbe, ❝ Well, it depends... Does it say whether this sample size was sufficient to conclude ? Maybe they tried their luck (as considered by Elena) and failed with a 90 % CI of 34 - 192 % Looks like both sponsors were lucky enough since the IMPs were successfully registered. See here and here. — Kind regards, Mittyri |
Ing. Helmut Schütz