A crucial regulatory step for development and approval of test substances that have high systemic exposure is Safety Pharmacology. Prior to phase I clinical trials, the effects of a therapeutic on the cardiovascular (CV) system, which is a vital organ system, should be evaluated and characterized. The Attentive Science safety pharmacologist combines his/her knowledge from Physiology, Pharmacology and Toxicology to evaluate effects on the electrocardiogram (ECG), with particular emphasis on ventricular depolarization and repolarization, as well as any potential effects on blood pressure (BP) and heart rate (HR).
ECG waveform interval and morphology changes are good biomarkers for assessing any potential electrophysiological effects of a therapeutic if there is a clear dose relation, subsequent to administration of the test substance. Similarly, an altered BP and HR is known to indicate a CV risk. The effect of a test substance on BP and HR is therefore also an important consideration in a benefit/risk analysis.
Focusing on In-vivo evaluation and using the intended clinical dose route, one needs to pay particular attention to the cardiovascular system. By determining the safety margin as well as performing a risk/benefit analysis in a dedicated study, you will then be able to provide safety assurance within your program as well as to your intended population. Everyone says it’s their people who make the difference, but we want you to know that one of our Attentive folks may be the difference to your program. Our CEO, Dr. Alfred Botchway spent multiple years serving on the Board of the Safety Pharmacology Society (SPS) and also served as President of the society. Pre-, peri- and post-society years of services, Dr. Botchway has been at the table with industry leaders heavily involved in reviewing, crafting and ensuring appropriate worldwide guidelines were instituted. You should want to work with a safety pharmacology society past president, as well as multiple scientists who have been active in the SPS for over 2 decades.
Everyone in the industry knows NHPs are hard to procure these days, but beyond that an Attentive Scientist can take care of your in-vivo CV safety pharmacology assessments. We will even go a step further to give you our opinion on data that may have been acquired at a different test site if that means safer remedies reach the intended population.
Our proven track record is within the archives of your company data/files so let’s have a discussion about your forthcoming programs. We look forward to talking to you all soon.