Pharmacodynamic

E 5 (R1) Ethnic Factors in the Acceptability of Foreign ...

and any preliminary pharmacodynamic and dose-response data, and 2) if needed, a bridging study to extrapolate the foreign efficacy data and/or safety data to the new region. A bridging study is defined as a study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new

  Pharmacodynamics

M4E(R2) - Common technical document for the registration ...

pharmacodynamic (PD), and related in vitro data in the CTD. The analysis should consider all relevant data and explain why and how the data support the conclusions drawn. It should emphasise unusual results and known or potential problems, or note the lack thereof. This section should address:

  Pharmacodynamics

Full year and Q4 2021 results

Jun 23, 2021 · 2021: strong results and accelerating momentum 5 Absolute values at actual exchange rates; changes at constant exchange rates (CER) and for the full year (FY) 2021, unless stated otherwise.