Be bioequivalence - Study guides, Class notes & Summaries

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 -manda...

Alabama MPJE All Answers Correct 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 -No...

Pharmacist mission improve public health through ensuring the safe, effective, and appropriate use of medications 4 main clinical pharmacy practice models pharmaceutical care MTM comprehensive med mgmt CDTM Goal of pharmaceutical care? optimize health related quality of life, achieve positive clinical outcomes Medication therapy management definition? CMS servive or group of services that optimizes therapeutic outcomes for individual patients. Optimize outcomes throug...

NYS MPJE PHARMACY LAW – 2024 WITH 100% CORRECT 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 - 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 util...

PC 707 Module 1 Exam - Questions and Answers Does a generic substitution contain the same amount of active drug as the brand name drug? -Yes -They are "essentially similar" -They have bioequivalence -The generic drug has to be within 80-125% of the same pharmacokinetics as the brand drug Do generic drugs and brand name drugs have the same bioavailability? No, just because they are bioequivalent (they have the same amount of the active drug) does not mean they have the same bioavailability (t...

NAPSR CNPR Exam - 14th Edition Correct answers latest update True or False? The FDA regulates the introduction of new drugs and enforces U.S. drug laws. True True or False? Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. True What is the average review time for a new drug? 18 months Sales Team (pg 7) Pg 7 What is considered the "engine of innovation," focused on dis...

Edmund’s Pharmacology Quiz 2 (Ch. 3-6, 33-34) Lippincott (CH. 41) || Questions & Answers (100% Verified) Edmund’s Pharmacology Quiz 2 (Ch. 3-6, 33-34) Lippincott (CH. 41) || Questions & Answers (100% Verified) Pharmacokinetics - ANSWER - the study of the action of drug sin the body, including the processes of absorption, distribution, metabolism, and elimination (how a body processes a drug) Absorption - ANSWER - how the drug leaves its site of administration Pharmacodynamics - A...

PTCB 2024 WALGREENS Exam Questions And Answers 100% Solved 2024 which organ in the body is primarily responsible for the metabolism of drugs? - answerliver what is bioequivalence? - answerdrug products that are pharmaceutical equivalents that have the same rate/extent of absorption when administered using the same dose of the active ingredient. what does ADME stand for in pharmacokinetics? - answerA - absorption D - distribution M - metabolism E - excretion/elimination what does NTI me...

What is the role of TGA? Regulation of the supply, import, export and manufacturing of therapeautic goods in Aus. What does the TGA classify as therapeutic goods? medications, supplments, complementary meds, medicine devices, tests/diagnostic materials, vaccines, biolgic products, sunscreen, surgical implants Aust L is? low risk medicines: vitaminsm herbals, no evidence assessed Aust R is ? registered meds, high risk What is an active ingredient ? chemical in the medicine that ...

Exam Master MA MPJE Review Test Accurate 100% Interchangeable multi-source drugs - ANSWER -Check Orange Book if "A" rating for same drug product, dosage form, strength -Same drug product, dosage form, strength assigned "A" rating in Orange Book and not listed on Exception List in MLID -If drug is not in Orange Book, it may still be interchangeable if same product, dosage form, strength listed in Additional List of MLID -Practitioner can instruct pharmacist to dispense only brand by ...