⭐ 7.5 Required Studies
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Research & Development
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Module 1: The Target Product Profile (TPP)
1.1 Introduction
⭐ 1.2 Sections of a TPP
⭐ 1.3 How to draft a TPP?
1.4 Benefits of a TPP
🔗 Additional Links & Resources
Module 2: CMC-Technical R&D
2.1 What is CMC or Technical R&D?
⭐ 2.2 Five Steps during the Product Development
⭐ 2.3 What are key elements of CMC?
🔗 Additional Links & Resources
Module 3: Good Manufacturing Practice
3.1 What is GxP?
⭐ 3.2 GMP vs. GDP
3.3 Main Areas of GMP Regulations
⭐ 3.4 Most Relevant GMP Principles
🔗 Additional Links & Resources
Module 4: Non-Clinical & Clinical Supply Chain
4.1 Supply Chain in the Biotech/Pharma Industry
⭐ 4.2 Drug supply for non-clinical studies
⭐ 4.3 Clinical Supply
4.4 Commercial Supply
🔗 Additional Links & Resources
Module 5: Medicinal Chemistry
5.1 What is Medicinal Chemistry?
5.2 Four Key Components in Medicinal Chemistry?
5.3 Challenges during Drug Discovery
⭐ 5.4 Main Properties to Optimize Starting from a Lead
5.5 What is “Druggability”?
5.6 Can Poor Absorption of a Compound be Predicted?
5.7 What is a Prodrug?
⭐ 5.8 List of Important Techniques Used in Drug Development & Medicinal Chemistry
5.9 Future Directions & Innovations in Medicinal Chemistry
🔗 Additional Links & Resources
Module 6: Scientific Advisory Boards for Biotech Companies
6.1 General
6.2 Pros & Cons for having a SAB
⭐ 6.3 Best Practice Principles for a Productive SAB
🔗 Additional Links & Resources
Module 7: Non-Clinical Safety
7.1 Introduction
⭐ 7.2 What is Non-Clinical Safety?
7.3 Toxicological Methodologies
7.4 Definitions & Standards of Non-Clinical Safety Studies
⭐ 7.5 Required Studies
⭐ 7.6 Specific Rules for Biologics
🔗 Links to Relevant ICH Guidelines: