CRP 101 Lecture 10 Flashcards
ADR marketed products definition
a response to drug that is noxious and unintended that occurs at doses normally used
good pharmacovigilance practices GVP
activites related to detection, evaluation, understanding, and prevention of ADR and drug related problems
MedWatch (FDA)
-patient or health care professional voluntarily report AE, quality issues, use error, therapeutic equivalence/failure, suspected counterfeit products
MedEffect Canada
consumers, health care professionals, manufactueres report side effects of health products to HC’s viglance program.
Vanessa’s Law
Canada, mandatory for hospitals to report serious ADRs and medical device incidents MDIs to HC
black box warning
drug carrier significant risk of serious or life threatening AEs
-i.e. antidepressants increasing suicidal thoughts, warfarin increasing bleeding.
drug warnings defintion
info provided by manufaturer on the package insert about ADRs.
drug recall
specific batch or lot of drug product recalled for quality issues that may compromise drug safety. (contamination, wrong expiration date)
drug withdrawal
serious AR or lack of efficacy, drug withdrawn from market by reg body
bioequivalence definition
high degree of similarty in bioavailabilities of two pharmaceutical produts of the same route of administration from same molar dose. Unlikely to produce clinically relevant differences in therapeutic effects, AEs or both
HC ANDS
abbreviated new drug submission - new drug is pharmaceutical equilaent of Canadian reference product on market, is bioequivalent, same route of administration, conditions of use the same.
bioequivalence study definition
designed to test the bioavailability of generic and brand products. Comparison o rate and extent of absorption of the active ingredient.
PD/PK
PD effect in body correlated to drug concentration (PK)
-measured in blood, conc versus time for PK, effect vs conc for PD
inference about bioequivalence (4)
-ref drug acceptabl safety and efficacy through CTs
-time-conc linked with therapeutic effect
-chemically equivelent (same amount active ingredient) and pharmaceutically equivalent (same doage form) have same rate and extent of absorption
-bioequivalent considered therapeuticlly equivalent
main criteria for bioequivalence
time-dependent concs of adminstered drug in blood samples after test and reference product
differences beween reference (brand) and test (generic) drug (3)
manufacturer
-excipients (inative ingredients)
-manufacturing process
similarities between reference (brand) and test (generic) drug (5)
-same active ingredients
-same strength (same amount of active ingredient)
-same route of administration
-same dosge form (tabet, etc)
-same therapeutic indications
bioequivalence study design
-health volunteers, normal weight, non-smokers, males and females 18-55yrs
-crossoover design or parallel design
primary endpoint: time-dependent concs of adminstered drug in blood samples after test and reference product
seondary enpoint: “ “ of metabolites in blood samples of eah subject “ “
tertiary endpoint: determine max, AUC, half-life, for the test and ref products
-subjects fast for 10 hours prior, highest safe dose taken with water, no fluids for 2 hours, no food for 4 hour, standardized meals, no reclining 2 hours, standardize posture and activity, 12-18 blood samples, including pre-dose.
drawn from 3 half-lives to captue 80% of AUC
-12 subjects or more
bioequivalence study exclusion criteria
-women of childbearing age if at risk
-no history of drug or alcohol abuse
-preferably no smoking
-no medications
-no allergy to test or reference
-no alcohol or OTC meds before study and after in specific timeframe
CRP 101 Lecture 11
