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Back to the forum  Query: 2018-05-21 11:09 CEST (UTC+2h)
 
Helmut
Hero
Homepage
Vienna, Austria,
2017-04-29 15:26

Posting: # 17280
Views: 2,022
 

 Revision of the BE-GL? [BE/BA News]

Dear all,

just discovered the Work plan for the Pharmacokinetics Working Party (PKWP) for 2017.*

2.2. EU Guidelines under revision

Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98 Rev.1
Target date

Concept paper to be released for public consultation Q4 2017.

Comments

A revision will be progressed in light of experience since the previous revision and taking account of a series of Questions & Answers and ongoing related work (see below).


Guideline on the investigation of bioequivalence (Appendix 1)
Target date

Finalise the discussion with BSWP and QWP on the acceptability of the Mahalanobis distance for the similarity of dissolution profiles.

Comments

This is a joint request from the CHMP Pharmacokinetics WP and the Quality WP.


Type I error control in two-stage designs in bioequivalence studies
Target date

BSWP to provide responses to PKWP by Q2 2017.

Comments

Finalise work related to type I error control in two-stage designs in bioequivalence studies. Collaboration with the Biostatistics Working Party.




  • The EMA doesn’t maintain a version control system (previous versions are overwritten by new ones). I will update the link once the document is archived at web.archive.org.

[image]Cheers,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
ElMaestro
Hero

Denmark,
2017-04-29 15:58

@ Helmut
Posting: # 17281
Views: 1,692
 

 ...and much more

Hi Hötzi,

yes, and there's no doubt there's going to be lots of interesting news in the coming years.
There's a WP dedicated to M&S which is picking up speed (there wouldn't be one if the general attitude towards M&S was entirely negative, would there?!?), and the OIP guideline from 2009 is also under revision which will create obstacles for some and pave ways forward for others.

And I was asked yesterday by an agency employee if we need a dedicated data integrity guideline and/or WP. I think this question was posed in view of the recent horror stories about BE CROs.

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).


Best regards,
ElMaestro

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.
Helmut
Hero
Homepage
Vienna, Austria,
2018-02-15 12:04

@ Helmut
Posting: # 18421
Views: 841
 

 Postponed: New target date Q4 2018

Dear all,

Guideline on the investigation of bioequivalence (Appendix 1)
Target date

Q4 2018 (+ one year)

Comments

This is a joint request from the CHMP Pharmacokinetics WP and the Quality WP. Following the publication of the Reflection Paper on statistical methodology for the comparative assessment of quality attributes in drug development, finalise the discussion with PKWP and QWP on the acceptability of the Mahalanobis distance for the similarity of dissolution profiles. The final output may be included in the aforementioned Reflection Paper or may form a Q&A.


Type I error control in two-stage designs in bioequivalence studies
Target date

Q4 2018 (+ 1½ years)

Comments

Finalise on-going discussion related to type I error in two-stage design bioequivalence studies. The final output will most likely form a Q&A (to be confirmed).


Sources: Work plan for the Pharmacokinetics Working Party (PKWP) for 2018, Work plan for the Biostatistics Working Party (BSWP) for 2018.

[image]Cheers,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
nobody
Senior

2018-02-15 12:24

@ Helmut
Posting: # 18422
Views: 835
 

 Postboned: New target date Q4 2018


Kindest regards, nobody
Helmut
Hero
Homepage
Vienna, Austria,
2018-02-15 13:32

@ nobody
Posting: # 18423
Views: 848
 

 Postponed: New target date Q4 2018

Hi nobody,

oops! Typo corrected. :-D

[image]Cheers,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
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