Biological products

>Tag:Biological products
24 01, 2013

Enrichment Strategies for Clinical Trials

By | 2016-10-12T14:35:11+00:00 January 24th, 2013|Categories: News|Tags: , , , , , , , , , |

Author: Steve Kates, Ph.D. A draft guidance has recently been issued (Dec 2012) entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” The document required more than 6 years to prepare and provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims. This guidance outlines three enrichment strategies. 1. Strategies to decrease heterogeneity [...]