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Helmut ★★★   Vienna, Austria, 2022-12-23 10:05 (717 d 16:42 ago) Posting: # 23409 Views: 6,289 |
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Dear all, the ICH Draft Guideline Bioequivalence for Immediate-Release Solid Oral Dosage Forms (M13A Step 2) was published yesterday. Note the new terminology: A – C instead of Tier 1 – 3 mentioned in the Concept Paper. — 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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Rasha_J ☆ Jordan, 2023-01-16 06:27 (693 d 20:20 ago) @ Helmut Posting: # 23422 Views: 4,999 |
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Thank you for the updates Is there a link to submit comments |
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Helmut ★★★ Vienna, Austria, 2023-01-16 10:19 (693 d 16:28 ago) @ Rasha_J Posting: # 23423 Views: 4,970 |
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Hi Rasha, ❝ Is there a link to submit comments As of today the guideline is not published by the EMA, FDA, and Health Canada. Too lazy to search other regions. I will keep you informed. — 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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SMA ☆ Europe, 2023-01-17 10:30 (692 d 16:17 ago) @ Rasha_J Posting: # 23424 Views: 4,986 |
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Dear Rasha_J Public consultations are launched regionally. You can track who has launched the consultation by accessing the ICH multidisciplinary guideline, and clicking the link within M13. So far, only TFDA Chinese Taipei has launched their consultation. Public consultation dates: TFDA, Chinese Taipei - Deadline for comments by 30 April 2023 ❝ Is there a link to submit comments Links to submit comments are made available by regional agencies once they open their consultation process. The more the scientific community contributes to the consultations (and use data to support recommendations, where possible), the better the chances that the ICH Expert Working Group can address the points. Best |
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dshah ★★ India, 2023-01-17 13:02 (692 d 13:45 ago) @ Rasha_J Posting: # 23426 Views: 4,867 |
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Hi Rasha_J! Below information might be helpful: "stakeholders from ICH Member countries/regions are encouraged to submit their comments to their respective Regulatory Authorities, noting the deadline for comments indicated beneath each draft Guideline. Stakeholders can also provide their comments by e-mailing the ICH Secretariat at [email protected]. For this purpose please make sure to use the ICH Template in Excel format. https://admin.ich.org/sites/default/files/2020-12/ICH_PublicConsultationComments_Template_Stakeholders_2020_1014.xlsx Please note that comments provided to the ICH Secretariat will be shared with the appointed participants of the relevant ICH Working Group responsible for the development of draft documents submitted to consultation." Regrards, Divyen |
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Rasha_J ☆ Jordan, 2023-01-18 10:53 (691 d 15:54 ago) @ Rasha_J Posting: # 23429 Views: 4,853 |
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Thank you for all  |
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Ohlbe ★★★ France, 2023-02-01 15:14 (677 d 11:33 ago) @ Rasha_J Posting: # 23437 Views: 4,587 |
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— Regards Ohlbe |
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Helmut ★★★ Vienna, Austria, 2023-02-09 13:34 (669 d 13:13 ago) @ Ohlbe Posting: # 23449 Views: 4,393 |
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Dear Ohlbe & all, two weeks ago the FDA’s CDER Small Business and Industry Assistance (SBIA) started a poll at LinkedIn. The question was: True or False: ICH Guidelines are developed through scientific consensus between international regulatory experts only. 31% (‼) of the 425 participants answered . Amazing.— 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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SMA ☆ Europe, 2023-02-08 10:10 (670 d 16:37 ago) @ Helmut Posting: # 23446 Views: 4,405 |
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Helmut ★★★ Vienna, Austria, 2023-09-18 12:54 (448 d 14:53 ago) @ SMA Posting: # 23719 Views: 3,250 |
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— 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