July 24, 2024

5.1 Clinical Research Pharm D Syllabus, Notes, PDF, Books, Downloads

5.1 Clinical Research Pharm D Syllabus, Notes, PDF, Books, Downloads

Drug development process:

Various Approaches to drug discovery

  1. Pharmacological
  2. Toxicological
  3. IND Application
  4. Drug characterization
  5. Dosage form

Clinical development of drug:

  1. Introduction to Clinical trials
  2. Various phases of a clinical trial.
  3. Methods of post-marketing surveillance
  4. Abbreviated New Drug Application submission.
  5. Good Clinical Practice – ICH, GCP, Central drug standard control organization (CDSCO) guidelines
  6. Challenges in the implementation of guidelines
  7. Ethical guidelines in Clinical Research
  8. Composition, responsibilities, and procedures of IRB / IEC
  9. Overview of the regulatory environment in the USA, Europe, and India.
  10. Role and responsibilities of clinical trial personnel as per ICH GCP
    a. Sponsor
    b. Investigators
    c. Clinical research associate
    d. Auditors
    e. Contract research coordinators
    f. Regulatory authority
  11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
  12. Informed consent Process
  13. Data management and its components
  14. Safety monitoring in clinical trials.

Fifth Year Pharm D Subjects

5.1Clinical Research
5.2Pharmacoepidemiology and Pharmacoeconomics
5.3Clinical Pharmacokinetics & Pharmacotherapeutic Drug Monitoring
5.5Project work (Six Months)

Suggested readings

Recommended readings: