5.1 What is Medicinal Chemistry?

Medicinal chemistry is the scientific endeavor that involves the design, synthesis, and evaluation of chemical compounds with the ultimate goal of discovering and developing new pharmaceutical agents. It integrates principles from organic chemistry, biochemistry, pharmacology, and molecular biology to understand the molecular mechanisms of diseases and to design compounds that selectively interact with biological targets.

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
  • πŸ”— 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?
  • πŸ”— 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
  • πŸ”— 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
  • πŸ”— 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 β€œDruggability”?
  • 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
  • πŸ”— 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
  • πŸ”— 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
  • πŸ”— Links to Relevant ICH Guidelines: