Acrp Ccra Exam Prep 100% Solution

ACRP CCRA Exam Prep 100% SOLUTION Phase I Trial AKA - ANSWER Human Pharmacology Phase I Trial - ANSWER -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 - ANSWER Therapeutic Exploratory Phase II Trial - ANSWER -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 - ANSWER Therapeutic Confirmatory Phase III Trial - ANSWER -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 - ANSWER Therapeutic Use Phase IV Trial - ANSWER -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 - ANSWER General Considerations for Clinical Trials Name of ICH E2A Guidance - ANSWER Clinical safety data management: definitions and standards for expedited reporting Name of ICH E9 Guidance - ANSWER Statistical Principles for Clinical Trials Name of ICH E11 Guidance - ANSWER CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION Name of ICH E6 Guidance - ANSWER Good Clinical Practice Non-clinical Trials - ANSWER Testing not done in humans ADME - ANSWER absorption, distribution, metabolism, excretion Pharmacokinetics - ANSWER the study of drug movement throughout the body Pharmacodynamics - ANSWER The study of what the drug does to the body Study Endpoints - ANSWER response variables that are chosen to assess drug effects that are related to PK parameters, PD measures, efficacy, and safety Primary Endpoint - ANSWER Should reflect clinically relevant effects and is typically selected based on principal objective of the study Secondary Endpoint - ANSWER Assess other drug effects that may or may not be related to the primary end point Single Blind Study - ANSWER A trial where the treatment assignment is no known by the study participant because of the use of placebo or other methods of masking the intervention. Double Blind Study - ANSWER Investigator, Sponsor staff, and subjects are all unaware of treatment assignments Primary Endpoint - ANSWER main measurement of a trial. Proportion of successes, time to a failure, measurable items (i.e. weight loss) Surrogate Endpoint - ANSWER use of substitute measures of outcomes that do not necessarily reflect the clinically important outcomes that a drug or other therapy intends to improve Null Hypothesis - ANSWER what you are trying to disprove Type I Error - ANSWER rejecting a true null hypothesis (false positive) Type II Error - ANSWER failing to reject a false null hypothesis (false negative) Five Characteristics of a Serious AE - ANSWER death, disability, birth defect, hospitalization, life threatening (Dr. Death Brings Healing Limbs) Adverse Event (AE) - ANSWER Any unfavorable or unintended medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) Adverse Drug Reaction (ADR) in clinical trials - ANSWER All noxious and unintended responses to a medicinal product related to any dose (causal relationship is a reasonable possibility) Adverse Drug Reaction in on market products - ANSWER A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis diagnosis or therapy of disease or for modification of physiological function Unexpected Adverse Drug Reaction - ANSWER An adverse event, the nature or severity of which is not consistent with the applicable product information Severe Adverse Event - ANSW