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Primary pharmacodynamic bioequivalence [Regulatives / Guidelines]

posted by ceylan – Turkey, 2021-11-19 16:46 (1280 d 17:24 ago) – Posting: # 22676
Views: 3,188

Hi,

For PK bioequivalence, 90% confidence interval is ok both for US and EMA.

For PD bioequivalence, I want to ask about the confidence interval for US and EMA?
Is it 90% CI for US and 95% CI for EMA?

And in what circumstances, 90 % CI and / or 95 % CI are being used?

Thank you,

Best Regards,

Ceylan

Complete thread:

Primary pharmacodynamic bioequivalenceceylan 2021-11-19 15:46 [Regulatives / Guidelines]
- Primary pharmacodynamic bioequivalence ElMaestro 2021-11-19 16:22
  - Primary pharmacodynamic bioequivalence ceylan 2021-11-20 23:14

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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body. Leslie Z. Benet

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