E-Library - Information At Your Fingertips: Printer Friendly 26 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 Before initial human studies are permitted, the full spectrum of pharmacologic properties of the new drug must be extensively investigated in animals. Animal researches are done to provide evidence that the drug has sufficient efficacy and safety to warrant testing in man. a) Pharmacodynamics - to identify the primary action of the drug as distinguished from the description of its resultant effects. - to delineate the details of the chemical interaction between drug and cell or specific receptor site(s), and - to characterize the full sequence of drug action and effects. i. Pharmacologic effects - properties relevant to the proposed indication and other effects. Pharmacodynamic data shall demonstrate the primary pharmacologic effect of the drug leading to its development for the intended use(s) or indication(s). It shall also show the particular tissue(s)/organ(s) affected by the drug and any other effect it produces on the various systems of the body. ii. Mechanism of action including structure-activity relationship (SAR) b) Pharmacokinetics Pharmacokinetic data form the basis for prediction of therapeutic doses and suitable dosage regimen. These data shall demonstrate the following: i. the rate and extent of absorption of the drug using the intended route of administration; ii. the distribution pattern including a determination of the tissues or organs where the drug and its metabolites are concentrated immediately after administration and the time course of their loss from this [sic] sites; iii. the metabolic pathway of the drug or its biotransformation and the biological metabolites; iv. the route of excretion of the drug and its principal metabolites and the amount of unchanged substance and metabolites for each route of excretion; v. the drug's half-life or the rate that it is eliminated from the blood, plasma or serum. 4/21/2020, 9:19 AM