3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

48based on scientific rationale. Also, the exclusion of certain test(s) or exploration(s) of certainorgans, systems or functions should be scientifically justified.1.2.1.1 Cardiovascular SystemEffects of the investigational drug should be studied on blood pressure, heart rate, andthe electrocardiogram. If possible in vitro, in vivo and/or ex vivo methods includingelectrophysiology should also be considered.1.2.1.2 Central Nervous SystemEffects of the investigational drug should be studied on motor activity,behavioral changes, coordination, sensory and motor reflex responses and bodytemperature.1.2.1.3 Respiratory SystemEffects of the investigational drug on respiratory rate and other functions suchas tidal volume and hemoglobin oxygen saturation should be studied.1.3 Follow-up and Supplemental Safety Pharmacology StudiesIn addition to the essential safety pharmacological studies, additionalsupplemental and follow-up safety pharmacology studies may need to beconducted as appropriate. These depend on the pharmacological properties orchemical class of the test substance, and the data generated from safetypharmacology studies, clinical trials, pharmacovigilance, experimental in vitroor in vivo studies, or from literature reports.1.3.1 Follow-up Studies For Essential Safety PharmacologyFollow-up studies provide additional information or a better understandingthan that provided by the essential safety pharmacology.1.3.1.1 Cardiovascular System