Case Studies and Regulatory Questions

In the VHP4Safety project, three case studies and two regulatory questions attributed to each case study are under research. Below are these case studies and regulatory questions.

  1. Kidney Disease: Disease scenario to study disease and pharmacovigilance.

  • a. What is the safe cisplatin dose in cancer patients?

  • b. How can we take into account variability in activity and expression of P-glycoprotein* in patients who underwent transplantation and treated with tacrolimus?

*P-glycoprotein 1 (permeability glycoprotein) also known as multidrug resistance protein 1 (MDR1) or ATP-binding cassette sub-family B member 1 (ABCB1) or cluster of differentiation 243 (CD243) an important protein of the cell membrane that pumps many foreign substances out of cells (UniProt:P08183).

  1. Life Course Pesticide Exposure and Neurodegenerative Disease: Life course exposure scenario to study life course exposure and neurodegenerative disease.

  • a. Can compound X cause Parkinson’s Disease?

  • b. Can we identify groups at extra risk of developing Parkinson’s Disease after exposure to compound Y?

  1. Thyroid Mediated Developmental Neurotoxicity: Age and sex scenario to study health effects discriminated by age and sex on thyroid mediated neurodevelopment.

  • a. What information about a compound (e.g., silychristin) do we need to advise women in their early pregnancy to decide whether the compound can be used?

  • b. Does compound Z (e.g., silychristin) influence the thyroid-mediated brain development in the fetus resulting in cognitive impairment in children?