Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Cardiovascular safety evaluations activity

Nonclinical safety pharmacology studies submitted to regulatory agencies are outlined in ICH Guidance S7A (2001), and the basic package includes evaluation of a drug candidate s effects on the central nervous system, respiration, and the cardiovascular system. Cardiovascular system evaluation includes assessment of cardiac function and cardiac electrophysiological activity. [Pg.14]

Effects of the compound on specific organ systems, i.e., cardiovascular, respiratory, and nervous, are evaluated. These are referred to as safety pharmacology studies and are intended to investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure. Parameters that are evaluated include blood pressure, heart rate, electrocardiogram, motor activity, behavioral changes, coordination, sensory/motor reflex responses, respiratory rate and depth (6,7). [Pg.61]

See other pages where Cardiovascular safety evaluations activity is mentioned: [Pg.743]    [Pg.277]    [Pg.62]    [Pg.64]    [Pg.45]    [Pg.148]    [Pg.200]    [Pg.377]    [Pg.540]    [Pg.875]    [Pg.117]    [Pg.737]    [Pg.387]    [Pg.508]    [Pg.553]    [Pg.672]    [Pg.8]    [Pg.39]    [Pg.362]    [Pg.3120]    [Pg.140]    [Pg.38]    [Pg.30]    [Pg.194]    [Pg.238]    [Pg.325]    [Pg.11]    [Pg.15]    [Pg.153]    [Pg.222]    [Pg.188]    [Pg.139]   
See also in sourсe #XX -- [ Pg.346 ]



SEARCH



Cardiovascular activity

Cardiovascular safety

Cardiovascular safety evaluations

Safety evaluation

© 2024 chempedia.info