1. DRUG DEVELOPMENT PROCESS
The drug development process is one of the most structured and regulated scientific journeys in modern healthcare. With rising healthcare needs and expanding innovation, developing a safe and effective drug…
2. INTRODUCTION TO CLINICAL TRIALS
Clinical trials form the backbone of modern medical research. They provide the scientific evidence required to evaluate new drugs, therapies, and diagnostic methods before they are approved for public use.…
3. VARIOUS PHASES OF CLINICAL TRIAL
The development of a new drug involves a rigorous and carefully monitored research process. After successful preclinical studies, a drug enters human testing through clinical trials. These trials follow a…
4. METHODS OF POST MARKETING SURVEILLANCE
Once a drug is approved and enters the market, the responsibility of monitoring its safety does not end. In fact, this is the stage where real-world evidence becomes crucial. Post…
5. GOOD CLINICAL PRACTICE – ICH, GCP
Good Clinical Practice (GCP) is the global ethical and scientific quality standard for conducting clinical trials involving human participants. The International Council for Harmonisation (ICH), previously known as the International…
6. GOOD CLINICAL PRACTICE – CDSCO GUIDELINES
In India, the conduct of clinical trials is governed by strict regulatory standards to ensure participant safety and scientific integrity. The Central Drugs Standard Control Organization (CDSCO), under the Ministry…
7. CHALLENGES IN THE IMPLEMENTATION OF GUIDELINES
Good Clinical Practice (GCP) guidelines ensure that clinical trials are ethical, scientific, and protective of participant safety. However, the successful implementation of these guidelines can be difficult, especially in developing…