wienui ★ Germany/Oman, 2019-04-14 13:51 (2198 d 23:04 ago) Posting: # 20157 Views: 7,264 |
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Dear All, I face a situation in the evaluation of a Bio-equivalence study which was conducted by a reference drug that was given to the subjects at the last month of it's shelf-life while the bio-analysis for the parent and it's active metabolites of this reference drug was happened after two months of expiration date of the reference drug. Please enlighten me if this case of Bio-analysis can be accepted. Best regards, Osama — Cheers, Osama |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2019-04-14 14:56 (2198 d 21:59 ago) @ wienui Posting: # 20158 Views: 6,457 |
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Dear Osama, ❝ […] a Bio-equivalence study which was conducted by a reference drug that was given to the subjects at the last month of it's shelf-life … Not optimal but still OK. ❝ … while the bio-analysis for the parent and it's active metabolites of this reference drug was happened after two months of expiration date of the reference drug. ❝ ❝ Please enlighten me if this case of Bio-analysis can be accepted. IMHO, yes (of course, if the long term stability of samples was validated).
Only if a new stock solution has to be prepared, either a new reference standard should be obtained or the identity/purity of the old reference standard re-established. — 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 |
jag009 ★★★ NJ, 2019-04-15 08:51 (2198 d 04:04 ago) @ wienui Posting: # 20160 Views: 6,405 |
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Hi, ❝ I face a situation in the evaluation of a Bio-equivalence study which was conducted by a reference drug that was given to the subjects at the last month of it's shelf-life... I had the issue 2 times before w FDA studies. As long as dosing is done there shouldn't be any issues. My studies completed dosing a week before the RLD expiry date. J |
wienui ★ Germany/Oman, 2019-04-15 22:58 (2197 d 13:57 ago) @ wienui Posting: # 20170 Views: 6,386 |
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Hi Helmut & John, Thank you for the reply. is there any guidance which I can refer to in this point? Best regards, Osama — Cheers, Osama |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2019-04-16 15:20 (2196 d 21:35 ago) @ wienui Posting: # 20173 Views: 6,519 |
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Hi Osama, ❝ is there any guidance which I can refer to in this point? For your specific case, none I’m aware of. But:
— 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 |
wienui ★ Germany/Oman, 2019-04-18 12:04 (2195 d 00:51 ago) @ Helmut Posting: # 20187 Views: 6,255 |
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Hi Helmut, ❝ Logic behind: When you weighed the standard in, it was within its shelf life and therefore, the concentration of the stock solution correct. The drug in the stock solution doesn’t “care” that the standard expired. Thank you for this logic explanation. I think as a regulatory person you must have a very vast academic scientific background in different fields beside to check every morning this forum otherwise you will lose. Have a nice day, Osama — Cheers, Osama |
d_labes ★★★ Berlin, Germany, 2019-04-20 22:46 (2192 d 14:09 ago) @ wienui Posting: # 20203 Views: 6,128 |
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Dear Osama, ❝ ... I think as a regulatory person you must have a very vast academic scientific background in different fields beside to check every morning this forum otherwise you will lose. Here I only could totally agree with you. Especially with the last statement concerning the BEBA forum.. For the beginning of your statement I'm not sure if regulatory persons full-fill the requirements you state very often. But thats another strory ... — Regards, Detlew |