Elena777
Junior

Belarus,
2019-03-13 17:17

Posting: # 20022
Views: 240
 

 Chloropyramine BE study [Power / Sample Size]

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!
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2019-03-13 18:08

@ Elena777
Posting: # 20024
Views: 227
 

 Pilot study

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?

Cheers,
Helmut Schütz
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Elena777
Junior

Belarus,
2019-03-13 18:55

@ Helmut
Posting: # 20028
Views: 226
 

 Pilot study

» 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]
mittyri
Senior

Russia,
2019-03-13 23:06

@ Elena777
Posting: # 20032
Views: 202
 

 GRLS data

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
Ohlbe
Hero

France,
2019-03-14 00:08

@ mittyri
Posting: # 20033
Views: 197
 

 GRLS data

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 % :crying:

Regards
Ohlbe
mittyri
Senior

Russia,
2019-03-14 11:28

@ Ohlbe
Posting: # 20034
Views: 156
 

 lucky sponsors

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 % :crying:

Looks like both sponsors were lucky enough since the IMPs were successfully registered. See here and here.

Kind regards,
Mittyri
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