CHAPTER 1-1.2 : Drug Development Process

Pharmacological approach, Toxicological approach


1. With schematic representation, discuss integrated drug development process.
2. Explain the different pharmacological action studies in the drug development process.
3. Explain pre-clinical trials.
4. Write a note ADME profiling.
5. Write a note on lead selection and optimization drug development process.
6. Explain the toxicological approach to drug development process.
7. Define therapeutic index.
8. Short note on Helsinki declaration.
9. What is LD50? and ED50.
10. What is Human Equivalent Dose (HED)? How to convert animal dose to HED?
11. Define Proof of Concept.
12. Define maximum tolerated dose.
13. Importance of chronic toxicity.
14. Mutagenecity and carcinogenicity.
15. Sub acute toxicity.

CHAPTER 1.3-1.5 : Drug Development Process

IND Application, Drug characterization, Dosage form


1. Discuss in detail the IND application.
2. What is IND? Enlist the different criteria for IND application.
3. Discuss various drug characterization techniques in drug development process.
4. Explain the importance of dosage form design in pre-clinical and clinical stages.
5. Biopharmaceutical classification of drugs.
6. Name the critical Pharmacokinetic parameter in drug development.
7. Drug bioavailability.
8. Fixed dose combinations.

CHAPTER 2-2.2 : Clinical development of drug

Introduction to Clinical trials, Various phases of clinical trial.


1. Requirements to conduct clinical trials as per schedule Y
2. Discuss in detail the various phases of clinical trial
3. explain inclusion and exclusion criteria in selection of clinical trial subjects
4. Explain the role of BPOs in conducting clinical research in India
5. Briefly explain phase 1 and phase 2 clinical trials
6. write short note on clinical trial design
7. objectives of phase 1/2/3/4
8. methods of randomization
9. difference between phase 2a and phase 2b
10. What is clinical trail
11. define single blind method
12. define double blind method
13. name different types of clinical trials
14. investigation product/drug
15. What is Belmont report?
16. Nuremberg trials
17. what is ‘The Orange Book’
18. Note on Non-inferiority clinical study
19. define bias
20. Regulations for orphan drugs
21. Regulations for Counterfeit drugs
22. drug labeling requirement in clinical studies
23. What is scurvy trail?
24. note on randomized clinical trial
25. define phase Zero
26. Note on open labeled clinical trails
27. Methods of sample size calculations in clinical trials
28. what are the objectives of phase 2 studies
29. Use of Placebo in clinical trials
30. principles of trial subject sampling

CHAPTER 2-3-2.4 : Clinical development of drug

Methods of post marketing surveillance, Abbreviated New Drug Application submission


1. Discuss about the different methods of post marketing surveillance.
2. Explain briefly about ANDA submission.
3. Explain in detail NDA submission.
4. Write a note on case control studies.
5. Difference between retrospective and prospective study.
6. Observational studies.
7. Write a note on meta analysis.
8. Write a note on ANDA.
9. Basic methodology and study designs of BA/BE studies.
10. Note on cohort studies.
11. Differentiate ADR and ADE.
12. Retrospective study.
13. Cross sectional study.
14. Epidemiological study.
15. Define false positive result with an example.
16. Write a note on ANDA.
17. Limitations of post marketing surveillance.

CHAPTER 2-5-2.6 : Clinical development of drug

Good Clinical Practice – ICH, GCP, Central drug standard control organization (CDSCO) guidelines, Challenges in the implementation of guidelines.


1. Discuss the principles of ICH-GCP guidelines.
2. Explain clinical trial protocol as per ICH-GCP guidelines.
3. Explain Clinical trials and monitoring. Discuss different types of monitoring visits in detail.
4. What do you mean by expedited reporting in clinical trial? Discuss the safety reporting as per schedule Y.
5. Discuss the recent amendments in schedule Y with special reference to ethics committee.
6. What the note on ICH-GCP guidelines.
7. Essential documents in conducting clinical trials.
8. Discuss in detail about CDSCO guidelines.
9. Write a short note on new amendments to Schedule Y.
10. What are medical devices and classify with suitable examples.
11. Statistical design in clinical trails.
12. Write a note on Clinical Study Reports.
13. Premature Termination or Suspension of a Study.
14. Selection and recruitment of Study Subjects.
15. Clinical Trials with Surgical Procedures / Medical devices.
16. Comment on the challenges in the implementation of ethical guidelines.
17. Role of ICMR in clinical research.
18. List the guidelines and acts that govern the conduct of clinical trials in India.
19. Selection and withdrawal of subjects in clinical trail.
20. Multicentre trails.
21. Preparative termination of clinical trail.
22. Unblinding.
23. Drug master file.
24. Subject identification code.
25. Note on CIOMS.
26. ICH E6.
27. Contract research.
28. Clinical trial registries.
29. Clinical trial insurance.
30. Comparative studies.
31. Coding of investigation products.
32. Importance of confidentiality statement in IB.
33. Phases of Vaccine Trials.
34. Non-Therapeutic Study.
35. Validation of clinical study.

CHAPTER 2-7-2.9 : Clinical development of drug

Ethical guidelines in Clinical Research, Composition, responsibilities, procedures of IRB / IEC, Overview of regulatory environment in USA, Europe and India


1. Write a note on clinical data management in clinical trials.
2. Explain clinical trials for vaccines.
3. Write a note on pharmaceutical regulations in regard to clinical trials in European union.
4. Write a note on Accelerated Approval, Fast Track, and Priority Review.
5. Pregnant women as research participant.
6. Explain the ethical guidelines for clinical research.
7. Write a note on compensation for clinical Trial subjects as per ethical guidelines.
8. Explain about conflict of interest in clinical trials.
9. Note on members of ICH.
10. Explain composition and responsibilities of IRB.
11. Discuss in detail about institutional review board.
12. What are different regulator system in USA, europe and India.
13. Give an overview of regulatory environment in India.
14. Expand forms of the following MHRA, CRO, CRF, MAH, EMEA, CTA, GLP, CFR.
15. Write a note on regulations for OFF-Label Use.
16. Write a note on Accelerated Approval.
17. Write a note on Fast Track, and Priority Review.
18. Note on research involving children.
19. Inclusion of pregnant women and nursing mothers in CT?
20. Explain vulnerable subject.
21. Define Ethics.
22. Ethical issues involved in Genetic Screening.
23. Note on members of ICH.
24. Write on European Clinical Directive.
25. Explain function of DCGI.
26. Note on 21CFR Part 312.
27. Note on Marketing Authorization Holder (MAH).
28. Note on centralized marketing and decentralized marketing.
29. Note on Clinical Trial Document (CTD).
30. Write a note on MHRA, EMEA and USFDA.

CHAPTER 2-10-2.12 : Clinical development of drug

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) and Informed consent Process.


1. Explain in detail the role and responsibilities of a)investigator b) clinical research associate c) Regulatory authority as per ICH-GCP.
2. Explain about clinical trials audit and inspection with special emphasis on national regulatory authorities.
3. Explain in detail the process of designing study protocol in clinical trials. Add a note on 4. Importance of CRF.
5. Write a note on CRA.
6. What is an Investigators brochure and explain its content?
7. Note on role and responsibilities of auditors.
8. Explain the role of investigators I clinical trials.
9. Role and responsibilities of sponsor in clinical trials.
10. Explain designing of CRF with a suitable example.
11. Discuss about designing of inform consent form for clinical study?
12. Explain in detail the informed consent process.
13. Expand the following: IND, DCGI, PvPI, BPO.
14. Role of CRC.
15. Role of auditor In clinical data.
16. Criterias for selection of investigators.
17. Define protocol.
18. Difference between consent and assent forms.
19. Explain Waiver of consent.

CHAPTER 2-13-2.14 : Clinical development of drug

Data management and its components, Safety monitoring in clinical trials.


1. Explain spontaneous reporting of ADR with suitable examples. What are the merits and demerits of spontaneous reporting.
2. Write a note on QA and QC.
3. Discuss data management and its component.
4. Write the application of computers in clinical data management.
5. Write a note on clinical data archive.
6. Discuss Electronic Data Processing.
7. Write about safety monitoring in clinical trails.
8. Explain the purpose of the clinical trial monitoring and the responsibilities of monitors in clinical monitoring.
9. Write a note on Active Surveillance in ADR reporting.
10. Role of Eudravigilance in safety monitoring.
11. What is ANOVA?
12. Role of DSMB in safety monitoring.
13. Components of documentation form.
14. List global ADR reporting Forms?
15. Define unexpected ADR.
16. Minimum criteria to report ADR.
17. List various criterias to classify a serious ADR.
18. Short note on PVPI, PSUR and SUSAR.
19. Role of Uppsala monitoring centre (UMC) in safety Monitoring

The following model questions are for the guidance of the candidates and academicians appearing and conducting PharmD exams. The question papers only serve the educational purpose of self evaluation and revision after the respective topic is read and understood. Hope you make the best use of them.