Unit 3 Part 2 | Industrial Pharmacy 2 · B Pharm 7th Semester (earlier PCI/CBCS syllabus)
Learn regulatory requirements for drug approval in Industrial Pharmacy 2 Unit 3 for B Pharm 7th semester.

Covered topics
Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.

Study this subject
https://www.youtube.com/playlist?list=PLacMvfuedRXNhDzUB_HGTdh38xwrjTn-x

Next lesson: Quality management systems
https://youtu.be/J1PY1USnB3E

Previous lesson: Regulatory affairs
https://youtu.be/ol14ZoP3iuQ

Study resources and links
Website: https://www.firsthope.co.in
Android app: https://play.google.com/store/apps/details?id=co.alexis.viki
iOS app: https://apps.apple.com/in/app/my-institute/id1472483563
Website: https://www.firsthope.co.in/b-pharm
Instagram: https://www.instagram.com/firsthope_pharmacy/
Android app: https://play.google.com/store/apps/details?id=co.alexis.viki&pcampaignid=web_share
Resource: https://chat.whatsapp.com/Hmw2llEfqWeFJ9ReaNENS8
Telegram: https://t.me/first_hope01
LinkedIn: https://www.linkedin.com/company/first-hope-fh/
Video or playlist: https://youtu.be/J1PY1USnB3E?si=dT82762mzUQELLk9
Video or playlist: https://youtu.be/rrtz28WAGhE?si=xel_uchiuAyYVg91
Video or playlist: https://youtu.be/9vthwKZlvr8?si=5tf2O6N1eHWyJfSa
Video or playlist: https://youtu.be/QajnsYipjQw?si=9exf4Ki75JcqEA-E
Video or playlist: https://www.youtube.com/live/v_CL4wPunKk?si=9wpI6rYOtSaVi03C
iOS organization code: DYFFUX