Unit 1
New Drug Discovery and Development
NotesPDF · 650 KB
Study Pharmaceutical Regulatory Science
Find Pharmaceutical Regulatory Science notes for B.Pharm Semester 8. Browse the available notes PDFs, video lessons and revision questions below and choose the unit or chapter you want to study.
Complete unit or chapter notes PDFs
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Unit 2
Regulatory Approval and Agencies
NotesPDF · 745 KB
Unit 3
Overseas Drug Registration
NotesPDF · 350 KB
Unit 4
Clinical Trials
NotesPDF · 583 KB
Unit 5
Regulatory Concepts
NotesPDF · 324 KB
Video lessons
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Unit 1Drug discovery and development2 videos
New drug discovery and development | Regulatory science | B Pharm 8th sem | Part 1
Drug development: preclinical studies, innovator and generic drugs | B Pharm 8th sem
Unit 2Regulatory approval processes2 videos
Regulatory approval process | Regulatory science | B Pharm 8th sem | Part 1
New Drug Application (NDA), ANDA, and comparison | Regulatory science | B Pharm 8th sem
Unit 3Overseas product registration2 videos
Regulatory authorities and agencies | Regulatory science | B Pharm 8th sem
Registration of Indian drug products in overseas markets | Regulatory science | B Pharm 8th sem
Unit 4Clinical trial regulation1 video
Clinical trials | Regulatory science | B Pharm 8th sem
Unit 5Regulatory concepts1 video
Regulatory concepts | Regulatory science | B Pharm 8th sem
PYQ & Important Questions
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Previous Year Questions
PYQs for this subject will be added later.
Important Questions
Original subject-specific practice questions for revision.
- Describe the relationship between drug development and regulatory submissions.
- Compare the purposes of investigational and marketing-authorisation dossiers.
- Explain the significance of harmonisation for overseas product registration.
- Discuss clinical-trial ethics and the role of regulatory oversight.
- Distinguish regulatory review, inspection and post-approval product surveillance.
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