CRP 101 Lecture 10

Question 1

ADR marketed products definition

Answer 1

a response to drug that is noxious and unintended that occurs at doses normally used

Question 2

good pharmacovigilance practices GVP

Answer 2

activites related to detection, evaluation, understanding, and prevention of ADR and drug related problems

Question 3

MedWatch (FDA)

Answer 3

-patient or health care professional voluntarily report AE, quality issues, use error, therapeutic equivalence/failure, suspected counterfeit products

Question 4

MedEffect Canada

Answer 4

consumers, health care professionals, manufactueres report side effects of health products to HC’s viglance program.

Question 5

Vanessa’s Law

Answer 5

Canada, mandatory for hospitals to report serious ADRs and medical device incidents MDIs to HC

Question 6

black box warning

Answer 6

drug carrier significant risk of serious or life threatening AEs
-i.e. antidepressants increasing suicidal thoughts, warfarin increasing bleeding.

Question 7

drug warnings defintion

Answer 7

info provided by manufaturer on the package insert about ADRs.

Question 8

drug recall

Answer 8

specific batch or lot of drug product recalled for quality issues that may compromise drug safety. (contamination, wrong expiration date)

Question 9

drug withdrawal

Answer 9

serious AR or lack of efficacy, drug withdrawn from market by reg body

Question 10

bioequivalence definition

Answer 10

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

Question 11

HC ANDS

Answer 11

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.

Question 12

bioequivalence study definition

Answer 12

designed to test the bioavailability of generic and brand products. Comparison o rate and extent of absorption of the active ingredient.

Question 13

PD/PK

Answer 13

PD effect in body correlated to drug concentration (PK)
-measured in blood, conc versus time for PK, effect vs conc for PD

Question 14

inference about bioequivalence (4)

Answer 14

-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

Question 15

main criteria for bioequivalence

Answer 15

time-dependent concs of adminstered drug in blood samples after test and reference product

Question 16

differences beween reference (brand) and test (generic) drug (3)

Answer 16

manufacturer
-excipients (inative ingredients)
-manufacturing process

Question 17

similarities between reference (brand) and test (generic) drug (5)

Answer 17

-same active ingredients
-same strength (same amount of active ingredient)
-same route of administration
-same dosge form (tabet, etc)
-same therapeutic indications

Question 18

bioequivalence study design

Answer 18

-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

Question 19

bioequivalence study exclusion criteria

Answer 19

-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

Question 20

CRP 101 Lecture 11