Pharmacy Freak Editorial Team

Introduction Ethics Committees play a critical role in safeguarding participant rights and ensuring ethical conduct of clinical research. This MCQ set on Working Procedures of Ethics Committees is designed for B. Pharm students to deepen understanding of protocol review, informed consent, risk–benefit assessment, continuing review, adverse event reporting, confidentiality, conflict of interest, SOPs, and regulatory … Read more

Institutional Review Board (IRB) and Ethics Committee structure MCQs With Answer The Institutional Review Board (IRB) and Ethics Committee structure is vital for B. Pharm students to understand clinical research governance, protocol review, informed consent, Good Clinical Practice (GCP) and regulatory compliance. This introduction explains committee composition, roles of chairperson, scientific and lay members, quorum, … Read more

Clinical trial protocol development steps are vital for B. Pharm students to understand practical drug research. A well-constructed clinical trial protocol defines study objectives, study design, inclusion/exclusion criteria, endpoints, sample size calculation, randomization, blinding, safety monitoring, data management, and regulatory & ethics requirements. Familiarity with protocol components—such as Investigator’s Brochure, case report forms, informed consent, … Read more

Introduction: Preparation and submission of regulatory dossiers is a core skill for B. Pharm students involved in pharmaceutical product approval. This topic covers dossier types (CTD, eCTD, DMF), module structure, CMC documentation, clinical and nonclinical data, stability studies, pharmacovigilance plans, and regulatory submission procedures. Understanding documentation standards, electronic submission formats, good documentation practice, and interactions … Read more

ASEAN Common Technical Document (ACTD) MCQs With Answer is an essential study resource for B. Pharm students preparing for regulatory affairs and drug registration roles. The ACTD harmonizes dossier structure across ASEAN countries, aligning quality, nonclinical and clinical modules with international CTD principles while keeping regional Module 1 requirements. Key keywords include ACTD, ASEAN Common … Read more