The potential of the estimands framework for clinical pharmacology trials: Some discussion points
| Autor: | Arne Ring, Martin J. Wolfsegger |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Pharmacology
medicine.medical_specialty Clinical pharmacology Computer science Ema Guidelines Guideline Bioequivalence Multiple dose 030226 pharmacology & pharmacy law.invention Clinical trial 03 medical and health sciences 0302 clinical medicine Therapeutic Equivalency Drug development Research Design law Data Interpretation Statistical Pharmacology Clinical medicine Humans Pharmacology (medical) Medical physics Statistical analysis 030212 general & internal medicine |
| Zdroj: | Br J Clin Pharmacol |
| ISSN: | 1365-2125 0306-5251 |
| DOI: | 10.1111/bcp.14233 |
| Popis: | The recently finalised and published guideline ICH E9 (R1) introduced a new framework for the statistical analysis of clinical trials, namely that of “estimands”. While the framework was originally developed for the analysis of late‐phase trials, it could also provide a rigorous basis for the analysis of clinical pharmacology trials. We illustrate potential applications on two examples: a multiple dose pharmacology trial and the interpretation of confirmatory bioequivalence (BE) trials according to the current FDA and EMA BE guidelines. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text