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

Drug development process:

Introduction
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
5.4Clerkship
5.5Project work (Six Months)

Suggested readings

  • BP804 ET: Pharmaceutical Regulatory Science Syllabus, Notes, MCQ, books, PDF
  • 3.5 Medicinal Chemistry Pharm D Notes, PDF, Books, MCQ, Downloads
  • Developing clinical trial protocols: Pharmaceutical Regulatory Science
  • BP801T MCQ Biostatistics and Research Methodology MCQ with Answers
  • 2.4 Pharmacology I Pharm D Syllabus, Notes, PDF, Books, Downloads, MCQ

Recommended readings:

  • Pharmaceutics I Theory
  • Pathophysiology
  • Computer Applications in Pharmacy Practical
  • Pharmaceutics I Practical
  • Definition and Scope Social Pharmacy
  • Social Pharmacy Theory
  • BIOSTATISTICS AND RESEARCH METHODOLOGY Theory
  • Pharmacovigilance Theory

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    August 16, 2022
  • Dr Yellapgrada Subba Rao

    August 9, 2022
  • Monkeypox updates: Home care

    August 6, 2022
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  • शैक्षणिक वर्ष 2022-23 मधील तांत्रिक व्यावसायिक अभ्यासक्रमांना प्रवेशासाठी लागणारी आवश्यक प्रमाणपत्रे
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B Pharmacy Notes (Subjectwise/Topicwise)

  • F Y B Pharmacy Notes
  • S Y B Pharmacy Notes
  • T Y B Pharmacy Notes
  • Final Year B Pharmacy Notes
  • B Pharmacy All Subject Notes

D Pharmacy Notes (Subjectwise/Topicwise)

  • 1st Year D Pharmacy
  • 2nd Year D Pharmacy

  • Books
  • Disease
  • Drugs
  • Jobs
  • News
  • pharma events
  • Pharma Industries
  • Pharmacy MCQ
  • Pharmacy Video Lectures
  • Uncategorized
  • ups and battery




  • शैक्षणिक वर्ष 2022-23 मधील तांत्रिक व्यावसायिक अभ्यासक्रमांना प्रवेशासाठी लागणारी आवश्यक प्रमाणपत्रे
  • Dr Yellapgrada Subba Rao
  • Monkeypox updates: Home care
  • KDLWS: Karnataka State Drugs Logistics & warehousing Society
  • The Pharmaceutical Regulatory Process




Telegram Groups

  • F Y D Pharm: t.me/fydpharm
  • S Y D Pharm: t.me/sydpharm
  • F Y B Pharm: t.me/fybpharmnotes
  • S Y B Pharm: t.me/sybpharmnotes
  • T Y B Pharm: t.me/tybpharm
  • Final Year B Pharm: t.me/finalyearbpharm







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