emka TECHNOLOGIES hosted a SPS hosted session on Assessment of Pressor Effects of Drugs on September 13th, 2022 in Montréal.
The effect of a drug on blood pressure is an important consideration in drug risk assessment and product labeling. Yet, in some cases the IND-enabling studies don’t include measurements of blood pressure according to regulatory guidelines, or don’t measure blood pressure adequately.
This scientific panel highlighted different perspectives, from a Contract Research Organization (CRO), from a pharmaceutical company, and from a regulator/clinical specialist to discuss best practices surrounding preclinical ICH S7A studies and premarketing assessment of a drug’s effect on blood pressure.
Dr.Christine Garnett (FDA), Dr.Todd Wisialowski (Pfizer) and Dr.Brian Roche (Charles River) presented their research interests and discussed:
- Guideline requirements and deviations from the guideline
- Preclinical vs. Clinical Blood pressure considerations (rodents, large animals, humans)
- Improvements to controls and sensitivity
- Considerations for drug class, target indication, patient population, magnitude of change, etc.
- BP assessment in vitro, ex vivo, in vivo