Topic outline
- 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:
1 ‘Non-clinical’ or ‘pre-clinical’?
2 In silico, in vitro, and in vivo studies
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
7 First dose estimation in human
8 Non-clinical outcomes that can stop the development
9 Specifics of non-clinical development for biological compounds
- 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 )
- 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:
- Reflective Questions on Patient Involvement
- End of Module Assessment