Скачать с ютуб Industrial pharmacy 7th semester important questions। Short & long questions with solution। Part-2। в хорошем качестве

Industrial pharmacy 7th semester important questions। Short & long questions with solution। Part-2।

Hey! My name is Shahruddin Khan Today In this video I provide Industrial Pharmacy 7th semester important questions with Pdf solution : Short & long important questions (Part-2) Download pdf notes of this video 📸 👇    • How to download Handwritten Notes fro...   Instrumental method of analysis Important questions👇(7th sem other subjects playlist)    • B Pharm 7th semester Important questions   _________________________________________ 💥 Subscribe Pharmacy wala 2.0 here🤌🫂    • Pharmacy wala 2.0 Intro। Learn about ...   ___________________________________________ Copyright disclaimer under section 107 of the copyright act 1976, allowance is made for ”fair use” for purposes such as criticism,comment ,news reporting , teaching,scholarship and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational and personal use tips the balance in favor of fair use. Follow on Instagram:- (Personal)   / shahruddinkhan921   Follow on Instagram:- (Channel)   / pharmacy_wala   / Like Facebook Page :- https://www.facebook.com/profile.php?... ___________________________________________ Join Telegram channel link 👇 •●◉✿Pharmacy wala✿◉●• It is an official telegram account of Pharmacy wala channel (shahruddin khan) Join this. https://t.me/pharmacywala15M Join whatsapp group👇 https://chat.whatsapp.com/ElxPp2Dt1a6... ____________________________________________ #analysis #industrialpharmacy #importantquestions #bpharmacy #7thsemester #syllabus #importantquestions #exam Unit-III Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals. Regulatory requirements for drug approval: 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. Unit-IV Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP. Unit-V Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.