Helmut ★★★ Vienna, Austria, 2010-03-28 19:28 (5135 d 19:14 ago) Posting: # 4978 Views: 3,258 |
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Dear all, a correction (dated 10 March 2010) was published recently. The new Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/Corr Changes (apart from a few typos): p10, 4th paragraph: 'kcal' instead of 'calories' p15, 5th paragraph: In specific cases of products with a narrow therapeutic range, the acceptance interval — 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 |
yjlee168 ★★★ Kaohsiung, Taiwan, 2010-03-29 15:36 (5134 d 23:06 ago) @ Helmut Posting: # 4980 Views: 2,523 |
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Dear Helmut, Thank you for your information. So it is just for the "immediate release dosage forms with systemic action" (page 4/27)of EXECUTIVE SUMMARY? — All the best, -- Yung-jin Lee bear v2.9.1:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
Helmut ★★★ Vienna, Austria, 2010-03-29 15:47 (5134 d 22:55 ago) @ yjlee168 Posting: # 4982 Views: 2,505 |
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Dear Yung-jin! ❝ So it is just for the "immediate release dosage forms with systemic action" Are you trying to confuse me? Yes, this guideline deals with immediate release formulations only. Or do you mean the 'standard meal', which is not a high fat, high calory meal like in 1999's MR-guideline? That's intentional. — 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 |
yjlee168 ★★★ Kaohsiung, Taiwan, 2010-03-29 15:55 (5134 d 22:46 ago) @ Helmut Posting: # 4984 Views: 2,520 |
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Dear Helmut, ❝ Are you trying to confuse me? Yes, this guideline deals with immediate release formulations only. Or do you mean the 'standard meal', which is not a high fat, high calory meal like in 1999's MR-guideline? That's intentional. Sorry about this. I just like to emphasize that this guideline is only for IR. Nothing else. Thanks. — All the best, -- Yung-jin Lee bear v2.9.1:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |