What is clinical development process?

Clinical Development, also called Drug Development, is a blanket term used to define the entire process of bringing a new drug or device to the market. It includes drug discovery / product development, pre-clinical research (microorganisms/animals) and clinical trials (on humans).

What are the clinical phases of drug development?


Phase Primary goal
Phase I Dose-ranging on healthy volunteers for safety
Phase II Testing of drug on participants to assess efficacy and side effects
Phase III Testing of drug on participants to assess efficacy, effectiveness and safety
Phase IV Post marketing surveillance in public

What is drug development in pharmacy?

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.

Why is the drug development process important?

The ultimate goal of drug development is to bring a new compound with proven therapeutic effect to the market. In this context, the transition from preclinical research to clinical stages marks a critical turning point, as it nears the new medicinal product to the market 3,4.

What are the four phases of a clinical trial?

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  • Phase 1. Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
  • Phase 2. Study Participants: Up to several hundred people with the disease/condition.
  • Phase 3. Study Participants: 300 to 3,000 volunteers who have the disease or condition.
  • Phase 4.

What are the stages of drug development process?

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What is the FDA process?

An Investigational New Drug application

  • Pre-licensure vaccine clinical trials
  • A Biologics License Application (BLA)
  • Inspection of the manufacturing facility
  • Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory Committee external icon (VRBPAC)
  • Usability testing of product labeling
  • What is Phase 3 drug testing?

    Phase 3, however, represents a pivotal point in a drug’s testing life cycle. It is the final and most comprehensive test a drug must pass before it can be sold.

    How does the FDA drug approval process work?

    The drug approval process takes place within a structured framework that includes: Analysis of the target condition and available treatments —FDA reviewers analyze the condition or illness for