Doctor of Pharmacy (Pharm.D) Fifth Year Clinical Research Notes PDF
1. Drug development process: Introduction Various Approaches to drug discovery
- Pharmacological
- Toxicological
- IND Application
- Drug characterization
- Dosage form
2. Clinical development of drug:
- Introduction to Clinical trials
- Various phases of clinical trial.
- Methods of post marketing surveillance
- Abbreviated New Drug Application submission.
- Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO) guidelines
- Challenges in the implementation of guidelines
- Ethical guidelines in Clinical Research
- Composition, responsibilities, procedures of IRB / IEC
- Overview of regulatory environment in 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.