Abstract

CLINICAL DEVELOPMENT AND THE DEVELOPMENT PROCESS INVOLVED IN BRINGING NEW MEDICINES TO THE MARKET

Saurabh D. Bhandare*

Abstract

There are multiple concerns involved in drug development process. The process involved has stage of development of drug molecule. This developed drug molecules are put forth to studies for proving its Quality, Efficacy and are validated for its procedural development upon a development of a drug molecule in a research laboratory. (Pharmaceutical Research Laboratory) it is evaluated for its therapeutic activity and are clinically tested and evaluated for its assigned activity. There are various drug regulatory agencies involved in this process and are based on continuous monitoring process that is called as ongoing monitoring. This monitoring are carried out by clinical experts such as: pharmacists and physicians. This clinical experts are involved in to assists the clinical safety data on a clinical safety evaluation of a drug molecule or an entity as an API. These studies are carried based on the guidelines that are accepted internationally. (ICH). One goal of such on-site monitoring is to ensure that you have the right information at right time and right place. Such on-site monitoring ensures that Healthcare is an excellent and most trusted industry that could provide and nurture mankind for its continuous advanced human health care to deliver valued and real outcome. Sustainability is a critical consideration and thus involves (OHDSI) in its safety monitoring process.

Keywords: Clinical development, Drug Molecules, Formulation Safety, Regulatory Agencies.