|B.Pharma| INDUSTRIAL PHARMACY-II Unit-3rd Best Handwritten Notes FreePDF Download |7th Semester|

INDUSTRIAL PHARMACY-II unit-3rd handwritten notes |7th Semester|

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

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Index

• 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

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