Clinical Research

ICH-GCP Principles

ICH GCP: ICH is the International Conference on Harmonisation of technical Requirements for Registration of Pharmaceuticals for Human Use.
-The current version of ICH was established in 1996 as a joint regulatory Industry/Project to improve the efficacy of process for developing and registering new medicinal products in Europe, Japan, and the US and observers: Canada, Australia, WHO, […]

By |December 8th, 2014|Clinical Research|0 Comments

Drug Development Process (Stages)


Drug Development Process:
Clinical Trials are highly regulated.When conducting trials with Investigational Products(Drugs) , Regulatory Authorities(RAs) require Good Clinical Practices(GCP) be followed.
-The GCP guidelines should be followed when generating clinical trial data that are intended o be submitted to Regulatory Authorities.
-The Principles established in GCP guidelines may also be applied to other clinical investigations that may […]

By |December 8th, 2014|Clinical Research|0 Comments

Clinical Research Introduction

Clinical Research is the study of a drug, Biologic or Device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. The product under Investigation is referred to as Investigational Product(IP).
-Clinical Research is patient oriented. It may be conducted in normal healthy volunteers or in people who have a specific disease or Illness. […]

By |December 8th, 2014|Clinical Research|0 Comments