Related Experiment Video
Updated: Feb 20, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape
Norbert Benda1, Andreas Brandt1
1a Biostatistics and Special Pharmacokinetics Unit , Federal Institute for Drugs and Medical Devices , Bonn , Germany.
Abstract:
Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.
More Related Videos
10:17High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
Published on: April 23, 2019
09:41An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells
Published on: July 15, 2015
Related Concept Videos
Drug Regulation
Drug Control Governance: Regulatory Bodies and Their Impact
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Drug Products: Biologics, Biosimilars and Interchangeables
Dosage Regimen: Individualization
FDA Approved Drugs: Changes to Approved Drugs