Challenges in the implementation of guidelines: Implementing Good Clinical Practice (GCP) guidelines is crucial for ensuring the ethical conduct and integrity of clinical trials. However, several challenges may arise during the implementation process. This article discusses ten common challenges faced…

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body in India responsible for ensuring the safety, efficacy, and quality of drugs and medical devices. CDSCO has established guidelines for Good Clinical Practice (GCP) to govern the conduct of…

Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific standards that ensure the design, conduct, and reporting of clinical trials. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed…

METHODS OF POST MARKETING SURVEILLANCE: Post-marketing surveillance (PMS) plays a vital role in monitoring the safety and effectiveness of medical products after they have been approved and made available to the public. This article provides a comprehensive overview of the…

VARIOUS PHASES OF CLINICAL TRIAL: Clinical trials are conducted in several phases, each serving a specific purpose in evaluating the safety, efficacy, and benefits of new treatments. This article provides a comprehensive overview of the different phases of clinical trials,…

INTRODUCTION TO CLINICAL TRIALS: Clinical trials play a pivotal role in advancing medical knowledge and bringing new treatments to patients. This article provides an introduction to clinical trials, covering their purpose, types, phases, and the concept of extended access protocols.…

Drug development process is a complex and intricate process that involves various stages, from drug discovery to dosage form development. This article provides an in-depth understanding of the drug development process, including its introduction, approaches to drug discovery, pharmacological testing,…