Pharmaceutical Development and Non-Clinical Testing

Topic outline

• Non-Clinical Testing and Pharmaceutical Development
  

  Non-Clinical Testing and Pharmaceutical Development
• Learning Outcomes
  

  Learning Outcomes

  • Lessons in this module will allow you to

    2A: Illustrate the choice and predictive value of the non-clinical testing programme as part of the overall medicine development plan (including scheduling of toxicology test with respect to clinical trials) for chemical and biological compounds

    2B: Describe the non-clinical development steps of medicines, explain the milestones a compound needs to go through during non-clinical development in order to progress to the next phase

    2C: Illustrate non-clinical outcomes that can stop the development of a medicine

    2D: Discuss the need and requirements for non-clinical studies prior to First-in-Man studies and the purpose of animal testing (including toxicology, pharmacology, non-clinical safety studies)

    2E: Outline the steps in the medicinal development of a medicines substance and final medicines product (including chemical and biological compounds)

    2F: Based on the understanding of blinding process, identify ways in which you, as patient advocate, can contribute to the choice of blinding mechanisms

    2G: Outline differences in generic development vs. classical medicine development

    2H: Describe guidelines for the use of generics

• Lesson 1: Basic Principles of Non-clinical Development
  

  Lesson 1: Basic Principles of Non-clinical Development

  Learning Outcomes

  2A Illustrate the choice and predictive value of the non-clinical testing programme as part of the overall medicine development plan (including scheduling of toxicology tests with respect to clinical trials) for chemical and biological compounds

  2B Describe the non-clinical development steps of medicines, explain the milestones a compound needs to go through during non-clinical development in order to progress to the next phase

  2C Illustrate non-clinical outcomes that can stop the development of a medicine 

  • Lesson 1:

  • Basic Principles of Non-clinical Development Book

    1 ‘Non-clinical’ or ‘pre-clinical’?

    2 In silico, in vitro, and in vivo studies

    3 What are the key aspects of Chemistry, Manufacturing, Control (CMC) during non-clinical development?

    4 Overview of non-clinical development

    4.1 Objectives of non-clinical development process

    4.2 Project management and the Target Product Profile (TPP)

    5 Non-clinical regulatory guidelines

    6 Non-clinical study types

    6.1 Pharmacodynamics (PD)

    6.2 Pharmacokinetics (PK)

    6.3 Toxicology

    7 First dose estimation in human

    8 Non-clinical outcomes that can stop the development

    9 Specifics of non-clinical development for biological compounds

    10 Conclusions

  • Further Reading and References (optional) Page
• Lesson 2: The Predictive Value of Non-Clinical Testing
  

  Lesson 2: The Predictive Value of Non-Clinical Testing

  Learning Outcomes

  • 2A Illustrate the choice and predictive value of the non-clinical testing programme as part of the overall medicine development plan (including scheduling of toxicology tests with respect to clinical trials) for chemical and biological compounds
  • 2D Discuss the need and requirements for non-clinical studies prior to First-in-Man studies and the purpose of animal testing (including toxicology, pharmacology, non-clinical safety studies )

  • The Predictive Value of Non-Clinical Testing (Part 1) Book

    1 Introduction

    2 From laboratory and animal studies to patients

    3 Non-clinical studies: Appropriate predictors for studies in humans?

    3.1 Animal models

    3.2 Specific animal models

    3.3 Animal models

    3.4 Specific animal models

    4 Timing of non-clinical studies to the clinical trial programme

    5 General toxicity studies

    6 Inclusion of women of childbearing potential in clinical trials

    7 Setting the 'First-in-Man' dose

  • Timing of Non-clinical Studies to the Clinical Trial Programme (Part 2) Book

    1 Introduction

    2 Repeated-dose toxicity

    3 General toxicity studies

    4 Systemic toxicity studies

    5 Reproductive toxicity studies

    6 Local tolerance studies

    7 Genotoxicity studies

    8 Carcinogenicity studies

  • Further Reading (Optional) Page
• Lesson 3: Basic Concepts and Requirements of Development of Galenic Formulations
  

  Lesson 3: Basic Concepts and Requirements of Development of Galenic Formulations

  Learning Outcomes

  • 2E Outline the steps in the medicinal development of a medicines substance and final medicines product (including chemical and biological compounds)

  • Lesson 3:

  • Basic Concepts and Requirements of Development of Galenic Formulations Book

    1 Introduction

    2 Formulation for non-clinical studies

    3 Formulation for clinical studies

    3.1 Polymers for continuous sustained release

    3.2 Solution for poorly soluble medicines

    3.3 Solutions for protein therapeutics

    4 Formulation testing

    5 Good Manufacturing Practice (GMP)

  • Further Reading (optional) Page
• Reflective Questions on Patient Involvement
  

  Reflective Questions on Patient Involvement

  • Question 4

  • Reflective Question 4: Advocating the importance of animal research URL
  • Question 5

  • Reflective question 5: What roles would you like to explore? URL
• End of Module Assessment
  

  End of Module Assessment