ICH Topic M 4 E Common Technical Document for the Registration
pharmacokinetics e.g.
Guideline on reporting the results of population pharmacokinetic
21 jun 2007 of the analysis plan for the population PK analysis is presented and ... This guideline applies to all Marketing Authorisation Applications ...
M4E(R2): The CTD — Efficacy Guidance for Industry
2.7.3.3.2 Comparison of Efficacy Results of all Studies . 5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports .
PK Data Explained
Results. Lab. Data (if required). ASL. AEX. PC. ALB. PK SAS Program(s): In all cases dates and date times are stored as character strings with a length ...
Guideline on PK Analyses - for consultation June 2006
29 jun 2006 GUIDELINE ON REPORTING THE RESULTS OF POPULATION PHARMACOKINETIC ... This guideline applies to all new Marketing Authorisation Applications ...
No Relevant Pharmacokinetic (PK) Interaction between Rezafungin
Results: The characteristics of the patients studied are pre- All patients were ... PK exposure of all drugs were similar with or without RZF.
