FUNDAMENTAL OF DRUG DEVELOPMENT
SHIREE KHAN FUNDAMENTAL OF
DRUG DEVELOPMENT
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
FUNDAMENTAL OF DRUG DEVELOPMENT
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
Course Title: FUNDAMENTAL OF DRUG DEVELOPMENT
Semester: II Course code: BCR203 Credits:03 Core
No of sessions Lectures / Tutorial: 30 No of practical hours: 0
Course Pre-requisites: Number of sessions: 30
Course Objectives:
This course provides an introduction to the scientific, ethical and regulatory aspects of clinical
research. Topics include basic principles and current methodologies used in the drug development
field and the conduct of clinical trials, including first-in-human studies (dose-finding, safety, proof of
concept, and Phase I), Phase II, Phase III, and Phase IV studies.
Course Learning Outcomes
Upon successful completion of the course, the students should be able to:
• The role of regulatory bodies in drug development
• The logistics of the drug development process
• Overview of regulations and guidance documents for drugs and biologics submissions
• Discuss content and requirements for the Investigational New Drug (IND) Application
• Review fundamentals of clinical trial structure and design, including Phases I-IV clinical studies
• Identify scientific and practical issues associated with the planning of a clinical research study
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
Course contents
Unit 1: Drug Development Process, Requirements and GCP Compliance: The drug development
process for FDA regulated studies; clinical trial regulatory requirements for drugs and biologics; overview
of regulatory requirements to plan, initiate and execute a clinical trial; GCP compliance to ensure ethical
and procedural conduct of clinical trials to produce high-quality data
Unit 2: Clinical Trial Design and Study Population Considerations: Developing clinical
trial/fundamental principles of prospective design; selecting a study population
Unit 3: The Investigational New Drug Application: Transition from pre-clinical to clinical phase of drug
development; review the Investigational New Drug (IND) content and application process for human
testing of drugs and biologics.
Unit 4: Safety Monitoring, GCP Regulations, Ethics and Informed Consent: Data Safety monitoring
committees (DSMBs), integrated safety summaries; safety reporting and requirements; Institutional
Review Boards (IRBs); ethical considerations and responsibilities of the parties involved in clinical
research; research ethics and informed consent implementation and the responsible conduct of research;
overview of required and optional elements of the Informed Consent Form (ICF) according to current FDA
and GCP ICH regulations
Unit 5: Assurance of Compliance and Quality in Clinical Research: Review of Industry Gold
Standards; Quality by Design (QbD) principles and Risk-Based Monitoring; applying a Quality Risk-
Management (QRM) approach in development of relevant Key Performance and Quality Indicators (KP-
QIs)
Course Assessment
Mid Term (30) End Term (70) Total
Attendance Assignment Theory(Test) Theory Practical
100
5 10 20 60 0
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
QUESTIONS
1. What does GCP stand for in clinical trials?
2. Describe the drug development process in FDA-regulated studies.
3. What is the purpose of an Investigational New Drug (IND) application?
4. Explain the role of Data Safety Monitoring Committees (DSMBs) in clinical trials.
5. What are the responsibilities of Institutional Review Boards (IRBs) in clinical research?
6. Why is informed consent important in clinical trials?
7. Define Quality by Design (QbD) principles.
8. What is Risk-Based Monitoring in clinical research?
9. What are Key Performance and Quality Indicators (KP-QIs) in clinical research?
10. How do regulatory requirements ensure GCP compliance in clinical trials?
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
Complex Questions
1. Analyze the transition process from pre-clinical to clinical phases of drug development.
2. Evaluate the ethical considerations involved in conducting clinical research.
3. Discuss the challenges associated with selecting an appropriate study population for clinical
trials.
4. Critically examine the role of integrated safety summaries in safety monitoring.
5. Assess the impact of Quality Risk-Management (QRM) approach on clinical research.
6. Compare and contrast the IND application process for drugs and biologics.
7. Examine the implications of non-compliance with GCP regulations in clinical trials.
8. Discuss the significance of Industry Gold Standards in ensuring compliance and quality in
clinical research.
9. Evaluate the effectiveness of Risk-Based Monitoring in improving the quality of clinical trials.
10. Analyze the ethical considerations surrounding the implementation of informed consent in
clinical trials.
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
Assignment Questions
1. Develop a comprehensive plan for transitioning a drug from pre-clinical to clinical phases.
2. Create an IND application package for a new drug candidate.
3. Design a protocol for a clinical trial, considering study population and design principles.
4. Analyze the safety monitoring procedures for a clinical trial and propose improvements.
5. Evaluate the ethical implications of a clinical trial protocol and suggest amendments.
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
Problem/Project-Based Learning Questions
1. Investigate a case of non-compliance with GCP regulations in a clinical trial and propose
corrective actions.
2. Develop a risk management plan for a clinical trial using Quality by Design (QbD) principles.
3. Conduct a mock IRB review of a clinical trial protocol and identify potential ethical concerns.
4. Design a patient recruitment strategy for a clinical trial, considering study population
demographics.
5. Implement a training program for clinical trial staff on GCP compliance and ethical conduct.
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
Match the Following
Match the regulatory agency with its country/region:
Regulatory Agency Country/Region
FDA United States
EMA European Union
MHRA United Kingdom
TGA Australia
Match the clinical trial phase with its description:
Clinical Trial Phase Description
Phase 1 Safety and dose-finding studies in a small group
Phase 2 Efficacy and side effects in a larger group
Phase 3 Expanded safety and efficacy in a larger population
Phase 4 Post-marketing surveillance
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
Multiple Choice Questions:
Which regulatory agency oversees drug development in the United States?
a) FDA
b) EMA
c) MHRA
d) TGA
What is the primary purpose of an Investigational New Drug (IND) application?
a) To obtain marketing approval
b) To initiate pre-clinical studies
c) To commence human testing of drugs
d) To conduct post-market surveillance
What is the responsibility of a Data Safety Monitoring Committee (DSMB) in clinical trials?
a) Reviewing adverse event reports
b) Monitoring patient recruitment
c) Analyzing study data
d) All of the above
What are the key elements of an Informed Consent Form (ICF) in clinical trials?
a) Participant demographics
b) Study risks and benefits
c) Investigator contact information
d) All of the above
What is the purpose of Quality by Design (QbD) principles in clinical research?
a) To ensure participant safety
b) To optimize trial efficiency
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
c) To minimize regulatory oversight
d) To streamline protocol development
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
FUNDAMENTAL OF DRUG DEVELOPMENT
SHIREE KHAN INSTITUTE OF CLINICAL RESEARCH INDIA, NEW DELHI
