Drug Development Phase 1

Examine the activities associated with phase 1 developnment, with a focus on the drivers that impact the design of the first-in-human study.

概要

The Drug Development Phase 1 module is part of the DIA Drug Development and Lifecycle Management eLearning Program. In this module, learners will be taken through the activities associated with phase 1 development, with a focus on the drivers that impact the design of the first-in-human study.

Estimated time to complete module: 1 hour

This eLearning module can be purchased individually or as part of the Drug Development and Lifecycle Management eLearning Program.

特集トピック

Objectives and key players
The IND and CTA
Phase 1 studies
Phase 1 decisions
Review

参加対象

This module is designed for individuals who are new to, or changing roles in, the pharmaceutical and biotechnology industries. The module will also benefit professionals who work in the areas of:

Clinical Research
Project Management
Administrative Support
Quality Assurance
Regulatory Affairs
Manufacturing
Medical writing
Business Support

学習目的

Upon completion of this module, learners should be able to:

Identify the key objectives of phase 1 studies
Determine the regulatory submissions required for phase 1 studies
List key activities that need to be completed before first-in-human clinical trials can begin
Recognize risk-return decisions involved in phase 1 studies

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