E-Library - Information At Your Fingertips: Printer Friendly 29 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 ii. Phase II Clinical Drug Trial Phase I Clinical Drug Trials are initial studies designed to evaluate efficacy of the study drug in a small number of selected populations or patient for whom the drug is intended which may be open label or single or double blind. Blood levels at various intervals, adverse experiences, and additional Phase I data may be obtained. Small doses are gradually increased until the minimal effective dose is found. All reactions of the subjects are carefully recorded. Preliminary estimates of the dosage, efficacy and safety in man are made. The second part of Phase II consists of pivotal well controlled studied that usually represent the most rigorous demonstrations of a drug efficacy. Relative safety information is also determined in Phase II studies. A larger number of patients are enrolled into the second part (N = 60 to 200 subjects). Phase II studies are conducted by accredited Clinical Pharmacologists. Phase II second part studies may be conducted by well qualified practitioners or clinicians who are familiar with the conditions to be treated, the drug used in these conditions to be treated, the drug used in these conditions and the methods of their evaluation. A written informed consent of patientsparticipants is needed. iii. Phase III Clinical Drug Trial Phase III clinical drug trials are studies conducted in patient populations for which the drug is eventually intended. These studies generate data on both safety and efficacy in relatively large numbers of patients under normal use conditions in both controlled and uncontrolled studies. The number of patients required vary [sic] (1,000 to 10,000). These studies provide much of the information that is needed for the package insert and labelling of the drug. This phase may be conducted as a multicentric trial among accredited clinicians. The informed consent of participating subject is preferably in written form. iv. Biovailability Bioavailability studies are conducted to determine the rate and extent to which the active substance or therapeutic moiety is absorbed from a pharmaceutical form and becomes available at the site of action. c) Name of investigator(s) and curriculum vitae d) Name(s) of center/institution wherein the clinical investigation was undertaken e) Protocol for local clinical trial[13] 4/21/2020, 9:19 AM