Clinical research according to ICH-GCP is defined as, “Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of […]
Gone are the days when clinical research and clinical trials used to be a concept only in the western world. Clinical trials are now a global phenomenon with giant pharma and biotech companies creating a paradigm shift by outsourcing clinical trials to third world developing countries. China, India, Latin America are few top contenders but […]
Indian-GCP: Yes, you must have heard about Indian GCP multiple times, but do we really know what Indian GCP is and why it was created? Do we know the differences between ICH (International Conference on Harmonisation)-GCP & Indian GCP?, and finally the important one… DO WE REALLY NEED IT? Let us try to find answers […]
Pre-clinical drug development process is a risk based process that involves safety and efficacy evaluation of drugs in animal species that extrapolate to potential human outcome. The pre-clinical pharmacologic and toxicological drug responses with respect to dose regimen and route of administration enable to initiate and continue research in human beings. In general, pre-clinical studies […]