This Blog is created for the updation of knowledge on Quality Assurance, current Good Manufacturing Practices (cGMP) and current Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs), specification and pharma jobs etc. for any Pharma plant.
Tuesday, December 7, 2010
E4: Dose-Response Information to Support Drug Registration
The tripartite harmonised ICH guideline was finalised (Step 4) in March 1994. This document gives recommendations on the design and conduct of studies to assess the relationship between doses, blood levels and clinical response throughout the clinical development of a new drug.