5.1 Clinical Research Pharm D Syllabus, Notes, PDF, Books, Downloads
Drug development process:
Introduction
Various Approaches to drug discovery
- Pharmacological
- Toxicological
- IND Application
- Drug characterization
- Dosage form
Clinical development of drug:
- Introduction to Clinical trials
- Various phases of a clinical trial.
- Methods of post-marketing surveillance
- Abbreviated New Drug Application submission.
- Good Clinical Practice – ICH, GCP, Central drug standard control organization (CDSCO) guidelines
- Challenges in the implementation of guidelines
- Ethical guidelines in Clinical Research
- Composition, responsibilities, and procedures of IRB / IEC
- Overview of the regulatory environment in the USA, Europe, and India.
- 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 - Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
- Informed consent Process
- Data management and its components
- Safety monitoring in clinical trials.
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
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
- B Pharmacy syllabus
- D Pharm PCI Syllabus