C2-M2 Non-Clinical Testing and Pharmaceutical Development

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Learning outcomes module 2:

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

2D:  Discuss the need and requirements for pre-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 the 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 drug developments

2H:  Describe guidelines for the use of generics


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