Clinical Research

Course Description

This comprehensive course on Clinical Research is designed for professionals and students who wish to gain a deep understanding of the clinical research process. Covering topics from introductory concepts to advanced bioequivalence studies and clinical trial phases, the course provides detailed insights into the methodologies, guidelines, and real-time applications in clinical research.

What You Will Learn

• Fundamental principles of clinical research and trial guidelines.
• Detailed processes involved in pre-clinical and clinical phases.
• In-depth knowledge of bioequivalence studies including clinical and analytical phases.
• Understanding various clinical trial phases (Phase I-IV) and their significance.
• Insights into special topics like clinical pharmacology, hypertension, and specific drug case studies.
• Hands-on experience with real-time tasks and case studies related to drug research.

Course Curriculum

• Introduction to Clinical Research
  • Overview of Clinical Research
  • Guidelines for Clinical Trials
  • Pre-clinical Studies
• Bioequivalence (BE) Studies
  • Introduction to BE Studies
  • BE Clinical Phase
  • Analytical Phase in BE Studies
  • BE Clinical Study Report (CSR)
  • Bioequivalence & Bioavailability
  • Bioequivalence Case Study: Metformin IR
  • Bioequivalence Study of Olmesartan
  • Topical Product Bioequivalence
• Clinical Trial Phases
  • Phase 1 Clinical Trials
  • Phase II, III, & IV Clinical Trials
  • Phase III IR
  • Phase 3 Rosuvastatin + Ezetimibe
• Special Topics in Clinical Research
  • Clinical Pharmacology
  • Hypertension and its Clinical Trials
  • Letrozole: A Case Study
  • Olmesartan IR: Clinical Study Overview

Real Time Tasks

• MetaforminIR_04
• Olmesartan IR_11
• Letrozole IR_18
• Phase 1 – Topical Product
• Phase III (Efficacy & Safety) Study of Rosuvastatin/Ezetimibe Tablets (FDC) in Hypercholesterolemia Volunteers