Research and Drug Development

The information and resources in this section can help you navigate in the Research and Drug Development area to identify issues classified for:
Disease models,
Disease/Translational resources,
Drug Discovery,
Clinical Development,

  1. Showing 15 results for:
  2. Research and Drug Development
All SubjectsRegulatory Affairs

AMED – Initiative on Rare and Undiagnosed Diseases

Published by IRDiRC

Regulatory AffairsOrphan Drug Development GuidelineAgency For Medical Research and DevelopmentInitiative on Rare DiseaseGenetic Analysis

Japan Agency for Medical Research and Development (AMED) leads the Initiative on Rare and Undiagnosed Diseases (IRUD) program. The program provides patients across Japan suffering from undiagnosed diseases with a diagnostic strategy that involves genetic analysis

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Extrapolation of efficacy and Safety in medicine development

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentClinical Trial DesignTarget PopulationStudy DesignExtrapolation of Efficacy and SafetyAdaptative Pathways

The EMA describes extrapolation as extending information and conclusions available from studies in one or more subgroups of the patient population (source population(s)), or in related conditions or with related medicinal products, in order to make inferences for another subgroup of the population (target population), or condition or product, thus reducing the amount of, or general need for, additional evidence generation (types of studies, design modifications, number of patients required) needed to reach conclusions.

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FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Regulatory AffairsClinical DevelopmentClinical Trial DesignRegulatory AdviceSpecial Protocol Assessment

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

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Decentralized trials 

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentClinical Trial DesignAdaptative PathwayDecentralised TrialPatient DataDigital Endpoint

Decentralized trials aim to improve patient access to trials by enabling patient follow-up from home or community care, increase the participation of more diverse populations, and enhancing data collection by combining the adoption of digital endpoints and telemedicine as applied to trials, decentralized trials aim

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpointBiomarkerAnimal ModelQualification ProcessDrug Development ToolCenter for Drug Evaluation and Research

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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