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.

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Fifth Year Pharm D Subjects

5.1	Clinical Research
5.2	Pharmacoepidemiology and Pharmacoeconomics
5.3	Clinical Pharmacokinetics & Pharmacotherapeutic Drug Monitoring
5.4	Clerkship
5.5	Project 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
• Social Pharmacy Practical D Pharm
• Pharmaceutical Biotechnology Theory

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