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drp ☆ India, 2018-08-10 09:09 (2076 d 05:46 ago) Posting: # 19162 Views: 4,207 |
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Dear All, My query is how is Sampling time points and number of sampling decided in bioequivalence study. Thanks and regards: drp Edit: Category changed; see also this post #1. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2018-08-10 13:51 (2076 d 01:04 ago) @ drp Posting: # 19165 Views: 3,538 |
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Hi drp, you need to know the PK of the drug (distribution, elimination) and the properties of the formulation (absorption, lag-time). For some general approaches see here and there. — 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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Durga ☆ India, 2018-08-14 09:37 (2072 d 05:18 ago) @ drp Posting: # 19167 Views: 3,373 |
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We need to check the molecule available PK profile of drug (absorption, distribution and elimination). we need to read the guidelines how many sampling time points need to be set at different phases as per above mentioned. you need to check the metabolite pharmacological activity (if applicable) bases on the formulation also. it is also very important. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5. Please follow the Forum’s Policy. [Helmut] |
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jag009 ★★★ NJ, 2018-08-18 02:17 (2068 d 12:38 ago) @ Durga Posting: # 19171 Views: 3,358 |
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❝ We need to check the molecule available PK profile of drug (absorption, distribution and elimination). we need to read the guidelines how many sampling time points need to be set at different phases as per above mentioned. "Read the guidelines how many sampling time points needed"? What guidelines? John |
Ing. Helmut Schütz