Preclinical drug trials Study guides, Class notes & Summaries

Generic Drugs - Chemicals that are produced by companies involved solely in the manufacturing of drugs Bioavailability of the drug may be different than brand name drug Less expensive than brand name drug DEA Schedule III (3 examples) - Less abuse potential than schedule II and moderate dependence liability Nonbarbiturate sedatives, nonamphetamine stimulates, limited amounts of certain narcotics Drug Evaluation: Preclinical Trials - Drugs are tested on laboratory ANIMALS to see if the dru...

ANSC 210 Final Exam Questions and Answers Already Passed Which of the following is TRUE? a. The number of animals used in research is increasing b. Animal research benefits both humans and animals c. In recent years, the life expectancy of people in the U.S. is increasing Animal research benefits both humans and animals The process of developing a new drug includes all of the following steps EXCEPT a. Advertising and sales b. Preclinical trials c. FDA approval d. Clinical tr...

definition of OTCs: : any drug purchased without a physicians prescription List 10 common OTC's: : 1. internal analgesics 2. cough and cold remedies 3. vitamins 4. laxatives 5. antacids 6. topical creams and ointments 7. sleeping aids 8. suncreens 9. antihistamines 10. anti-acne agents Who controls sale of OTC's? : -the government -the "Food and Drug Act" controls safety, efficacy, advertising and sale How is safety of OTC drugs determined? : -preclinical testing -post-market su...

What must you file before conducting human clinical trials with an experimental drug? Correct Answer IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials un...

Which of the following is TRUE? a. The number of animals used in research is increasing b. Animal research benefits both humans and animals c. In recent years, the life expectancy of people in the U.S. is increasing : Animal research benefits both humans and animals The process of developing a new drug includes all of the following steps EXCEPT a. Advertising and sales b. Preclinical trials c. FDA approval d. Clinical trials : Advertising and sales The document that must be approved b...

DDS Exam 1 Questions With 100% Correct Answers define indication specific use for a drug -its labeled use [FDA approved] 2 other names for psuedopolymorphs hydrates or solvates 2 requirements for FDA approval to market a drug product -show safety and efficacy -shop process control and validation (will they work the same every time) 2 main stages of drug development process are preclinical and clinical (study done in humans) 4 steps of drug discovery 1. "target" identification and ...

Katzung & Trevor's Pharmacology: Examination and Board Review INTRODUCTION 1. A 3-year-old is brought to the emergency department having just ingested a large overdose of tolbutamide, an oral antidiabetic drug. Tolbutamide is a weak acid with a pKa of 5.3. It is capable of entering most tissues, including the brain. On physical examination, the heart rate is 100/min, blood pressure 90/50 mm Hg, and respiratory rate 20/min. Which of the following statements about this case of tolb...

____ rule calculates drug dosages based on the child's weight - Clarks ______ rule uses the childs weight and age (after 1 year) to calcuate drug dosages - Young's _______ ________ prevent the HIV 1 virus from entering the cell by stopping fusion of the virus with the human cellular membrane - Fusion inhibitors ___________ are used during preclinical trials to test the effects of drugs on live tissue - Lab animals ___________ drugs are helpful in treating rare diseases and have not been ...

Tolerance may develop to some effects of a drug but not to others correct answer: true Which of the following accurately describes the influence that age has on drug effects? correct answer: children and the elderly are more susceptible to a drug's effects Sensation-seeking is correct answer: a personality characteristic that is associated with more frequent and varied substance use Some of the effects of alcohol are greater when blood alcohol level is rising than when blood alcohol...

PHARMACOLOGY TESTBANK TEST 1 WITH 100% CORRECT QUESTIONS AND ANSWERS A postoperative patient reports pain, which the patient rates as an 8 on a scale of 1 to 10. The prescriber has ordered acetaminophen 650mg PO every 6 hours PRN. What will the nurse do? Contact the provider to request a different analgesic medication. A patient newly diagnosed with diabetes is to be discharged from the hospital. The nurse teaching the patient about home management should begin by doing what? Asking the patien...