| Chapter No | Topics | Questions | Marks |
|---|---|---|---|
| 1 | Introduction | Drug Development Process With schematic representation, discuss integrated drug development process. | 5 |
| 1.1 | Pharmacological approach | Define therapeutic index Short note on Helsinki declaration --- Content provided by FirstRanker.com --- What is LD50? and ED50What is Human Equivalent Dose (HED)? How to convert animal dose to HED? Explain the different pharmacological action studies in the drug development process explain pre-clinical trials write a note ADME profiling --- Content provided by FirstRanker.com --- Define Proof of Conceptdefine maximum tolerated dose Write a note on lead selection and optimization drug development process. | 2 2 2 --- Content provided by FirstRanker.com --- 25 5 5 2 --- Content provided by FirstRanker.com --- 25 |
| 1.2 | Toxicological approach | Importance of chronic toxicity Explain the toxicological approach to drug development process mutagenecity and carcinogenicity Sub acute toxicity | 2 --- Content provided by FirstRanker.com --- 52 2 |
| 1.3 | IND Application | Discuss in detail the IND application What is IND? Enlist the different criteria for IND application | 10 5 |
| 1.4 | Drug characterization | Discuss various drug characterization techniques in drug development process | 5 |
| 1.5 | Dosage form | biopharmaceutical classification of drugs --- Content provided by FirstRanker.com --- name the critical Pharmacokinetic parameter in drug developmentdrug bioavailability Fixed dose combinations Explain the importance of dosage form design in pre-clinical and clinical stages | 2 2 --- Content provided by FirstRanker.com --- 22 5 |
| 2.1 | Introduction Clinical trials | Clinical Development of Drug Requirements to conduct clinical trials as per schedule Y What is clinical trail --- Content provided by FirstRanker.com --- define single blind method | 10 2 2 |
| 2.2 | Various phases of clinical trial | explain inclusion and exclusion criteria in selection of clinical trial subjects define double blind method name different types of clinical trials --- Content provided by FirstRanker.com --- investigation product/drugWhat is Belmont report? Nuremberg trials Explain the role of BPOs in conducting clinical research in India what is 'The Orange Book' --- Content provided by FirstRanker.com --- Note on Non-inferiority clinical studydefine bias Regulations for orphan drugs Regulations for Counterfeit drugs drug labeling requirement in clinical studies --- Content provided by FirstRanker.com --- What is scurvy trail?Discuss in detail the various phases of clinical trial note on randomized clinical trial Briefly explain phase 1 and phase 2 clinical trials write short note on clinical trial design --- Content provided by FirstRanker.com --- define phase Zeroobjectives of phase 1/2/3/4 methods of randomization Note on open labeled clinical trails Methods of sample size calculations in clinical trials --- Content provided by FirstRanker.com --- difference between phase 2a and phase 2bwhat are the objectives of phase 2 studies Use of Placebo in clinical trials principles of trial subject sampling | 5 2 --- Content provided by FirstRanker.com --- 22 2 2 5 --- Content provided by FirstRanker.com --- 22 2 2 2 --- Content provided by FirstRanker.com --- 22 10 2 5 --- Content provided by FirstRanker.com --- 52 5 5 2 --- Content provided by FirstRanker.com --- 25 2 2 2 |
| 2.3 | Methods of post marketing surveillance | Discuss about the different methods of post marketing surveillance --- Content provided by FirstRanker.com --- write a note on case control studiesdifference between retrospective and prospective study observational studies write a note on meta analysis note on cohort studies --- Content provided by FirstRanker.com --- differentiate ADR and ADEretrospective study cross sectional study Epidemiological study Define false positive result with an example | 10 --- Content provided by FirstRanker.com --- 55 5 5 2 --- Content provided by FirstRanker.com --- 22 2 2 2 |
| 2.4 | Abbreviated New Drug Application submission | explain briefly about ANDA submission --- Content provided by FirstRanker.com --- Explain in detail NDA submissionwrite a note on ANDA basic methodology and study designs of BA/BE studies limitations of post marketing surveillance | 10 10 --- Content provided by FirstRanker.com --- 55 2 |
| 2.5 | Good Clinical Practice ICH, GCP, Central drug standard control organization (CDSCO) guidelines | discuss the principles of ICH-GCP guidelines explain clinical trial protocol as per ICH-GCP guidelines Explain Clinical trials and monitoring. Discuss different types of monitoring visits in detail --- Content provided by FirstRanker.com --- What do you mean by expedited reporting in clinical trial? Discuss the safety reporting as per schedule Ydiscuss the recent amendments in schedule Y with special reference to ethics committee what the note on ICH-GCP guidelines essential documents in conducting clinical trials Discuss in detail about CDSCO guidelines --- Content provided by FirstRanker.com --- Role of ICMR in clinical researchlist the guidelines and acts that govern the conduct of clinical trials in India selection and withdrawal of subjects in clinical trail multicentre trails Write a short note on new amendments to Schedule Y. --- Content provided by FirstRanker.com --- what are medical devices and classify with suitable examplespreparative termination of clinical trail statistical design in clinical trails unblinding drug master file --- Content provided by FirstRanker.com --- subject identification codewrite a note on Clinical Study Reports Note on CIOMS Premature Termination or Suspension of a Study ICH E6 --- Content provided by FirstRanker.com --- contract researchclinical trial registries clinical trial insurance comparative studies coding of investigation products --- Content provided by FirstRanker.com --- importance of confidentiality statement in IBPhases of Vaccine Trials | 10 10 10 10 --- Content provided by FirstRanker.com --- 105 5 5 2 --- Content provided by FirstRanker.com --- 22 2 5 5 --- Content provided by FirstRanker.com --- 25 2 2 2 --- Content provided by FirstRanker.com --- 52 5 2 2 --- Content provided by FirstRanker.com --- 22 2 2 2 |
| 2.6 | Challenges in the implementation of guidelines | Clinical Trials with Surgical Procedures / Medical devices. --- Content provided by FirstRanker.com --- comment on the challenges in the implementation of ethical guidelines | 5 5 |
| 2.7 | Ethical guidelines in Clinical Research | write a note on clinical data management in clinical trials research involving children Inclusion of pregnant women and nursing mothers in CT? vulnerable subject --- Content provided by FirstRanker.com --- define EthicsEthical issues involved in Genetic Screening explain clinical trials for vaccines pregnant women as research participant Explain the ethical guidelines for clinical research --- Content provided by FirstRanker.com --- write a note on compensation for clinical Trial subjects as per ethical guidelinesConflict of interest in clinical trials | 10 2 2 2 --- Content provided by FirstRanker.com --- 22 5 5 5 --- Content provided by FirstRanker.com --- 55 |
| 2.8 | Composition, responsibilities, procedures of IRB / IEC | members of ICH explain composition and responsibilities of IRB Discuss in detail about institutional review board | 2 5 --- Content provided by FirstRanker.com --- 5 |
| 2.9 | Overview of regulatory environment in USA, Europe and India | write on European Clinical Directive function of dcgi Note on 21CFR Part 312 Note on Marketing Authorization Holder (MAH) note on centralized marketing and decentralized marketing --- Content provided by FirstRanker.com --- Note on Clinical Trial Document (CTDMHRA EMEA USFDA what are different regulator system in USA, europe and India --- Content provided by FirstRanker.com --- give an overview of regulatory environment in Indiaexpand forms of the following MHRA, CRO, CRF, MAH, EMEA, CTA, GLP, CFR write a note on regulations for OFF-Label Use Write a note on pharmaceutical regulations in regard to clinical trials in European union | 2 2 --- Content provided by FirstRanker.com --- 22 2 2 2 --- Content provided by FirstRanker.com --- 22 5 5 5 --- Content provided by FirstRanker.com --- 510 |
| 2.10 | Role and responsibilities of clinical trial personnel as per ICH GCP | Write a note on Centralized procedure and Decentralized Mutual Recognition Procedure in European union write a note on Accelerated Approval write a note on Accelerated Approval, Fast Track, and Priority Review write a note on Fast Track, and Priority Review --- Content provided by FirstRanker.com --- write a note on CRAExplain in detail the role and responsibilities of a)investigator b) clinical research associate c) Regulatory authority as per ICH-GCP explain about clinical trials audit and inspection with special emphasis on national regulatory authorities Expand the following: IND, DCGI, PvPI, BPO role of CRC --- Content provided by FirstRanker.com --- Role of auditor In clinical dataWhat is an Investigators brochure and explain its content? role and responsibilities of auditors explain the role of investigators I clinical trials criterias for selection of an investigator/s --- Content provided by FirstRanker.com --- Role and responsibilities of sponsor in clinical trials | 10 5 10 5 5 --- Content provided by FirstRanker.com --- 1010 2 2 2 --- Content provided by FirstRanker.com --- 55 5 2 5 |
| 2.11 | Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment) | Explain in detail the process of designing study protocol in clinical trials. Add a note on importance of CRF --- Content provided by FirstRanker.com --- explain designing of CRF with a suitable examplecrine protocol | 10 5 2 |
| 2.12 | Informed consent Process | Discuss about designing of inform consent form for clinical study? explain confidentiality and impartial witness --- Content provided by FirstRanker.com --- Explain in detail the informed consent processdifference between consent and assent forms explain Waiver of consent | 5 2 5 --- Content provided by FirstRanker.com --- 22 |
| 2.13 | Data management and its components | write a note on QA and QC Discuss data management and its component write the application of computers in clinical data management write a note on clinical data archive --- Content provided by FirstRanker.com --- What is ANOVA? | 5 5 5 5 2 |
| 2.14 | Safety monitoring in clinical trials | Role of DSMB in safety monitoring --- Content provided by FirstRanker.com --- Components of documentation formDiscuss Electronic Data Processing Explain the monitoring visits in initiation, conduction and closing of clinical trial List global ADR reporting Forms? Define unexpected ADR --- Content provided by FirstRanker.com --- Minimum criteria to report ADRList various criterias to classify a serious ADR write about safety monitoring in clinical trails Explain the purpose of the clinical trial monitoring and the responsibilities of monitors in clinical monitoring PVPI --- Content provided by FirstRanker.com --- PSURSUSAR write a note on Active Surveillance in ADR reporting Role of Eudravigilance in safety monitoring Role of Uppsala monitoring centre (UMC) in safety Monitoring --- Content provided by FirstRanker.com --- Explain spontaneous reporting of ADR with suitable examples.What are the merits and demerits of spontaneous reporting | 2 2 5 10 --- Content provided by FirstRanker.com --- 22 2 2 5 --- Content provided by FirstRanker.com --- 52 2 2 5 --- Content provided by FirstRanker.com --- 52 10 |
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