Be bioequivalence - Study guides, Class notes & Summaries

Bioequivalence Definition Pharmaceutical equivalents that display the SAME RATE and EXTENT OF ABSORPTION Means delivering the SAME AMOUNT of ACTIVE DRUG moiety to SITE OF ACTION when GENERIC or INNOVATOR drugs are administered at the same molar dose under SIMILAR CONDITIONS Therapeutic Equivalents Definition Considered equivalent when the GENERIC drugs are PHARMACEUTICAL EQUILVALENTS and show SAME EFFICACY, SAFETY PROFILE as product whose efficacy and safety has been established Pharmaceuti...

NJ MPJE QUESTIONS AND ANSWERS ALREADY PASSED Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - misbranding Pure Food and Drug Act (1906) description -mandated accurate p...

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension - correct answer SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... - correct answer Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? - correct answer 1) Seizure of drugs 2) Crimin...

NJ MPJE EXAM | QUESTIONS & ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ Neither _____ nor _____ are required by an *ANDA*. Correct Answer: -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. Correct Answer: -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. Correct Answer: -misbrand...

Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-Humphrey Amendment -Not required to have directions for ...

US RAC Practice Exam 2016 Test Bank Questions and Answers All Correct (Verified Answers) According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record. B: Device master record. C. Complaint files. D. Design history file. - Explanation: A. This contains the dates of manufactured, the quantity manufactured, the quantity released for distribution, control numbers used and the ...

Prodrug - Answer An inactive drug dosage form that is converted to an active metabolite by various biochemical reactions once it is inside the body. -Cytochrome P450 -Ex. Aspirin, psilocybin, heroin Bioavailability - Answer the rate at and the extent to which a nutrient is absorbed and used -Affected by route of administration and drug dosage -Drug clearance (rate drug leaves circulation) -Steady state concentration -Affected by chemical stability, solubility, and first pass Steady stat...

Alabama MPJE Questions and Answers Already Passed Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-Humphrey A...

NJ MPJE EXAM 2024 WITH 100% CORRECT ANSWERS Neither _____ nor _____ are required by an *ANDA*. - correct answer -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. - correct answer -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - correct answer -misbranding Pure Food and Dr...

Neither _____ nor _____ are required by an *ANDA*. Correct Answer: -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. Correct Answer: -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. Correct Answer: -misbranding Pure Food and Drug Act (1906) description Correct Answer: -mandated accura...