Be bioequivalence - Study guides, Class notes & Summaries

Pharmacology Exam1 StudySet (Weeks1 - 3) Questions And Answers2024/2025All Answers Correct Verified Best Graded A+ For SuccessPharmaceutical Equivalents Definition - CORRECT ANSWERSConsidered equivalents when BOTH AGENTS contain IDENTICALAMOUNTS of ACTIVE ingredients in the same SALT or ESTERform, ROUTE of administration and possess IDENTICAL disintegrationTIMES, and DISSOLUTION rates. Bioequivalence Definition - CORRECT ANSWERS Pharmaceutical equivalents that display the SAME RATE and EXTENT O...

clinical medical work that relates to the examination and treatment of ill people therapeutics use of drugs and the method of there administration in the treatment of disease clinical therapeutics use of drugs in the treatment of disease that relates to patients TGA therapeutics goods administration regulates supply, import, export, manufacturing and advertising of therapeutic goods to ensure safe use of medications medicine labelling generic = lower case (warfarin) brand =...

CT MPJE QUESTIONS AND ANSWERS RATED A+ How many total CE hours are required to be completed upon the second renewal of a pharmacists license in CT? 15 When would a partially filled methylphenidate Rx for a patient not in a long-term care facility expire? 72 hours When would a phoned-in, emergency oxycodone prescription expire? Dispensing limited to emergency period When would a written bupropion prescription expire? "no expiration" When would a electronic alprazolam prescription expire? 6...

Latest NJ MPJE Practice Test |100% Correct Answers| Neither _____ nor _____ are required by an *ANDA*. *Ans* -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. *Ans* -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. *Ans* -misbranding Pure Food and Drug Act (1906) description *Ans* -...

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

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

Alabama MPJE Exam Studt Set |Question and Answers| #Latest Relaese Pure Food and Drug Act (1906) aka Wiley Law *Ans* Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) *Ans* -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) *Ans* -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufa...

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 answers SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... correct answers Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? correct answers 1) Seizure of drugs 2) Criminal ...

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

Pharmacy Law - MPJE NYS Exam Questions And Answers 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 - ANS SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... - ANS Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? - ANS ...