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

49These include ventricular contractility, vascular resistance and the effects ofchemical mediators, their agonists and antagonists on the cardiovascularsystem.1.3.1.2 Central Nervous SystemThese include behavioral studies , learning and memory, electrophysiologystudies , neurochemistry and ligand binding studies.1.3.1.3 Respiratory SystemThese include airway resistance, compliance, pulmonary arterial pressure,blood gases and blood pH.1.3.2 Supplemental Safety Pharmacology StudiesThese studies are required to investigate the possible adverse pharmacologicaleffects that are not assessed in the essential safety pharmacological studies andare a cause for concern.1.3.2.1 Urinary SystemThese include urine volume, specific gravity, osmolality, pH, proteins,cytology and blood urea nitrogen, creatinine and plasma proteins estimation.1.3.2.2 Autonomic Nervous SystemThese include binding to receptors relevant for the autonomic nervous system,and functional response to agonist or antagonist responses in vivo or in vitro,and effects of direct stimulation of autonomic nerves and their effects oncardiovascular responses.1.3.2.3 Gastrointestinal SystemThese include studies on gastric secretion, gastric pH measurement, gastricmucosal examination, bile secretion, gastric emptying time in vivo andileocaecal contraction in vitro.1.3.2.4 Other Organ SystemsEffects of the investigational drug on organ systems not investigated elsewhereshould be assessed when there is a cause for concern. For example dependencypotential, skeletal muscle, immune and endocrine functions may beinvestigated.