Bioequivalence and Bioavailability Forum • Island country (time to leave the EU?)

Helmut
★★★

Vienna, Austria,
2011-12-16 21:31
(5310 d 13:24 ago)

Posting: # 7786
Views: 3,449

Island country (time to leave the EU?) [Regulatives / Guidelines]

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Dear all,

just received a deficiency letter from the UK.

Please provide the name and the location of the study site.
Please provide the name and professional address of the principal investigator.
Please provide justification for performing the study in fasted state. The comparator does not provide the recommendation regarding the fasted or fed state for dosing.
Please confirm whether the period or sequence effects were observed in the study. Please provide a comment on their relevance for the study results if they were observed.

Well:

Given on the title page of the report, the synopsis, Section 6, and, …
Given in the synopsis, Sections 5.4 and 16.1.4
“In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations. For products where the SmPC recommends intake of the reference medicinal product on an empty stomach or irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions.”
Since nothing was stated in the reference’s SmPC the study was performed in fasted state.
“A test for carry-over is not considered relevant and no decisions regarding the analysis (e.g. analysis of the first period only) should be made on the basis of such a test. The potential for carry-over can be directly addressed by examination of the pre-treatment plasma concentrations in period 2 (and beyond if applicable).”
Not a single pre-dose value >BQL; period and sequence >0.38 for all metrics. Tables were provided in the report.

What the heck? :angry:

OK, OK, (3) and (4) are really very, very difficult issues – but (1) and (2)?!

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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ElMaestro
★★★

Denmark,
2011-12-17 18:22
(5309 d 16:33 ago)

@ Helmut
Posting: # 7789
Views: 2,798

Island country (time to leave the EU?)

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Dear Helmut,

❝ :angry: OK, OK, (3) and (4) are really very, very difficult issues – but (1) and (2)?!

Relax, relax. Just take your medicine and close your eyes and breathe slowly. It'll all be good again very soon.

At least these questions can be answered. Would be good if all deficiency letters were like that wouldn't it?

But why does your client pass such deficiencies on to you at all? Too difficult for the CPM to manage?

Best regards,
EM.

Helmut
★★★

Vienna, Austria,
2011-12-17 18:59
(5309 d 15:56 ago)

@ ElMaestro
Posting: # 7790
Views: 2,822

Island country (time to leave the EU?)

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Hi ElMaestro!

❝ Relax, relax. Just take your medicine and close your eyes and breathe slowly.

Yeah, I did (like ev’ry day).

❝ At least these questions can be answered. Would be good if all deficiency letters were like that wouldn't it?

Howgh!

❝ But why does your client pass such deficiencies on to you at all? Too difficult for the CPM to manage?

They know that I’m simply faster by a factor of 100 at least. ;-)

P.S.: Happy birding!

—
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,
2011-12-17 21:39
(5309 d 13:16 ago)

@ Helmut
Posting: # 7791
Views: 2,839

Island country (time to leave the EU?)

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Hi HS,

❝ P.S.: Happy birding!

Thank you. I have to say, though, that so far it's miserable. The weather is crap. I left the grey and rainy...erm...Belgium...only to get to the grey and rainy Florida. Seems ridiculous. Only a few loggerhead shrikes and the usual assortment of vultures and white herons sp. spotted so far. Some very tasty poultry in my lunch sandwich makes partially up for it. Perhaps I should check out the local beach (West Palm) tomorrow as I hear female chicks can be a rather pleasant sight despite their winter plumage.

Best regards,
EM.