ACRP CCRA Exam Prep Questions and Answers 100% Pass

ACRP CCRA Exam Prep Questions and Answers 100% Pass Phase I Trial AKA Human Pharmacology Phase I Trial -Assess tolerance. -Define/describe PK and PD. -Explore drug metabolism and drug interactions, estimate activity. -Done in healthy volunteers.10 -100 people Phase II Trial AKA Therapeutic Exploratory Phase II Trial -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying to find therapeutic dose. 50 - 500 subjects with specific diseases. -Several months to two years in duration Phase III Trial AKA Therapeutic Confirmatory Phase III Trial -Demonstrate/confirm efficacy. -Establish safety profile. -provide an adequate basis for assessing risk/benefit. -Establish dose-response relationship. -Can include several hundred to several thousand.Usually lasts a few years Phase IV Trial AKA Therapeutic Use Phase IV Trial -Refine understanding of risk/benefit in general or special populations. -Identify less common AEs/ Refine dosing recommendation. -Anyone seeking treatment from their physician. Thousands of subjects. Lasts for many years Name of ICH E8 Guidance General Considerations for Clinical Trials Name of ICH E2A Guidance Clinical safety data management: definitions and standards for expedited reporting Name of ICH E9 Guidance Statistical Principles for Clinical Trials Name of ICH E11 Guidance CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION Name of ICH E6 Guidance Good Clinical Practice Non-clinical Trials Testing not done in humans ADME absorption, distribution, metabolism, excretion Pharmacokinetics the study of drug movement throughout the body Pharmacodynamics The study of what the drug does to the body Study Endpoints response variables that are chosen to assess drug effects that are related to PK parameters, PD measures, efficacy, and safety Primary Endpoint Should reflect clinically relevant effects