averroes1304 ☆ Morocco, 2019-03-27 12:55 (2147 d 14:16 ago) (edited on 2019-03-27 13:51) Posting: # 20091 Views: 7,725 |
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Dear all, could you explain to me the importance of bioanalytical validation in bioequivalence studies? is it really critical and important to perform the bioanalytical validation exercise? knowing that the purpose of bioequivalence studies is only to highlight differences in bioavailability between the test and reference drug and that this difference will be highlighted in all cases even with an invalidated analytical method and that chance cannot be the only factor in case of bioequivalence between two drugs with an invalidated analytical method..... is it scientifically acceptable to use analytical methods published in the literature? Best regards, Edit: Category changed; see also this post #1. [Mittyri] |
ElMaestro ★★★ Denmark, 2019-03-27 13:08 (2147 d 14:03 ago) @ averroes1304 Posting: # 20092 Views: 6,978 |
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Hello Averroes, if you cannot reliably determine the concentrations in PK samples, then you cannot reliably evaluate bioequivalence. At the end of the day the comparative evaluation of rate and extent of absorption is based on quantification in PK samples. Thus, in highly regulated markets you will not see products approved unless the reliability of the assay has been confirmed by a validation. Check also ICH E6 e.g. §2.2 and §2.5 or similar entries in WHO's set of practices. — Pass or fail! ElMaestro |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2019-03-27 15:41 (2147 d 11:30 ago) @ ElMaestro Posting: # 20093 Views: 6,869 |
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Hi ElMaestro, x=c("Foo", "Bar") ![]()
![]() — 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 |
ElMaestro ★★★ Denmark, 2019-03-27 16:35 (2147 d 10:36 ago) @ Helmut Posting: # 20094 Views: 6,862 |
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Hi Hötzi, yes you are right as most often. It reminds me of the good old days when Delphi was a thing. Borland wrote a very comprehensive manual spanning across 5 million gazillion pages. Only problem was, you had to be a Delphi expert in order to understand any word of it. This was a standing joke in the programming community back then, around 1998-2003 or so. ![]() — Pass or fail! ElMaestro |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2019-03-27 19:48 (2147 d 07:23 ago) @ ElMaestro Posting: # 20095 Views: 6,822 |
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Hi ElMaestro ❝ It reminds me of the good old days when Delphi was a thing. […] Oh dear, already the pointers in Pascal drove me nuts. BTW, Delphi – what a name! Only topped by a company marketing databases called Oracle. What about “I will consult the Delphic oracle!”… I still have Sobell’s “A practical guide to UNIX System V” in my bookshelf. 700 completely incomprehensible pages. You have to be a nerd with horn-rimmed glasses living from pizza, burgers, and Red Bull to value vi or EMACS.* Given, powerful stuff but for an average person like attempting to climb the K2 in shorts and sneakers.
— 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 |
nobody nothing 2019-03-27 20:01 (2147 d 07:10 ago) @ Helmut Posting: # 20096 Views: 6,919 |
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vi is cool... and absolutely sick at the same time. But after 5 min you will get the basics with the two modes etc. Btw: Bioanalytical method validation is very important, if you want to do your study not only for the rubbish bin (or a poster at some congress) but plan to market the formulation you test for human use. — Kindest regards, nobody |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2019-03-27 20:16 (2147 d 06:55 ago) @ nobody Posting: # 20097 Views: 6,798 |
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Hi nobody, ❝ vi is cool... and absolutely sick at the same time. Yep, I used it on HP-UX those days. Concerning the latter quoting wiki again: Due to the unintuitive character sequence* to exit vi, hackers joke that there is a proposed method of creating a pseudorandom character sequence by having a user unfamiliar with vi seated in front of an open editor and asking them to exit the program. ❝ But after 5 min you will get the basics with the two modes etc. Sure but the basics will not help too much.
— 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 |
nobody nothing 2019-03-27 20:38 (2147 d 06:33 ago) @ Helmut Posting: # 20098 Views: 6,882 |
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...to create a new system file somewhere on the root partition or copy&paste sumefink to a config file (if there is no nano or alike) it's OK ![]() — Kindest regards, nobody |
Shuanghe ★★ Spain, 2019-03-28 14:59 (2146 d 12:12 ago) @ Helmut Posting: # 20102 Views: 6,693 |
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Hi, ❝ Due to the unintuitive character sequence* to exit vi, hackers joke that there is a proposed method of creating a pseudorandom character sequence by having a user unfamiliar with vi seated in front of an open editor and asking them to exit the program. Saw one similar on Reddit but far from random. The generated texts would be like "quitquitexitqescapequit!q()fuck!ESCgetout()...." you get the idea... ![]() ❝ ❝ But after 5 min you will get the basics with the two modes etc. I use vi only on my home PC where only Linux in installed, and only occasionally. for a few editting on system config files, even nano suit me. vi is terrible, and EMACS is not anything better for me. Don't understand why each time you search best text editor those two are always on top.— All the best, Shuanghe |
ElMaestro ★★★ Denmark, 2019-03-27 23:07 (2147 d 04:04 ago) @ Helmut Posting: # 20099 Views: 6,751 |
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Hi Hötzi, ❝
This is much like my former girlfriend. One for every occasion you could think of, plus bonus rounds with added aggression. To me this all resulted in syntax errors. We aren't together any more. — Pass or fail! ElMaestro |
Ohlbe ★★★ France, 2019-03-28 11:28 (2146 d 15:43 ago) @ ElMaestro Posting: # 20100 Views: 6,791 |
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Hi there, ❝ ❝
❝ This is much like my former girlfriend. One for every occasion you could think of, plus bonus rounds with added aggression. To me this all resulted in syntax errors. ❝ ❝ We aren't together any more. Apart from the first two, I think this is the only post in this thread which I'm able to understand ![]() Bioanalytical method validation can have consequences not planned in the ICH M10 draft. — Regards Ohlbe |
nobody nothing 2019-03-28 12:14 (2146 d 14:57 ago) @ Ohlbe Posting: # 20101 Views: 6,747 |
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...and even worse (re Danish footer) The FDA ordered AbbVie to stop recruiting multiple myeloma patients for a Phase III trial of its anti-cancer drug Venclexta/Venclyxto. Forty-one out of 194 patients taking AbbVie’s Venclexta (venetoclax) in the company’s trial have died, the FDA found, nearly twice the percent of the patients in the trial’s placebo arm. — Kindest regards, nobody |