Australia’s = EMA’s MR guideline [Regulatives / Guidelines]
Hi Muthu Raj,
Here you err. Om Prakash is dealing with a modified-release product. Hence, the respective guideline should be observed (as mentioned by Dan above).
❝ The European Union guidelines adopted in Australia
❝ Primary PK Parameter: AUC0-t and Cmax
❝ Secondary PK Parameter: Tmax
Here you err. Om Prakash is dealing with a modified-release product. Hence, the respective guideline should be observed (as mentioned by Dan above).
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-23 12:21 [Regulatives / Guidelines]
- PK Parameters for Bioequivalent Criteria Dr_Dan 2017-01-23 13:32
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-28 07:17
- PK Parameters for Bioequivalent Criteria Muthu Raj 2017-02-04 12:58
- Australia’s = EMA’s MR guidelineHelmut 2017-02-04 18:25
- Australia’s = EMA’s MR guideline Muthu Raj 2017-02-06 12:01
- Australia’s = EMA’s MR guidelineHelmut 2017-02-04 18:25
- PK Parameters for Bioequivalent Criteria Muthu Raj 2017-02-04 12:58
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-28 07:17
- PK Parameters for Bioequivalent Criteria Dr_Dan 2017-01-23 13:32