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Helmut ★★★   Vienna, Austria, 2017-04-29 17:26 (2935 d 00:52 ago) Posting: # 17280 Views: 7,377 |
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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. CommentsA 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. CommentsThis 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. CommentsFinalise work related to type I error control in two-stage designs in bioequivalence studies. Collaboration with the Biostatistics Working Party.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2017-04-29 17:58 (2935 d 00:20 ago) @ Helmut Posting: # 17281 Views: 6,072 |
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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. — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2018-02-15 13:04 (2643 d 04:14 ago) @ Helmut Posting: # 18421 Views: 5,217 |
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Dear all, Guideline on the investigation of bioequivalence (Appendix 1) Target date Q4 2018 (+ one year) CommentsThis 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) CommentsFinalise 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. — 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 |
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nobody nothing 2018-02-15 13:24 (2643 d 03:54 ago) @ Helmut Posting: # 18422 Views: 5,229 |
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— Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2018-02-15 14:32 (2643 d 02:46 ago) @ nobody Posting: # 18423 Views: 5,210 |
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Hi nobody, oops! Typo corrected.  — 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 |
Ing. Helmut Schütz