Preclinical drug trials - Study guides, Class notes & Summaries

How new drugs are developed - Preclinical stage- the early part of drug development. Identification of promising drugs and animal testing occurs during this stage. Testing on cells, organs, and tissues also occurs in the labs. - Toxicologists specialize in understanding the harmful effects of drugs and predicting as early as possible in the development process if a drug will harm patients. - Phase 1 clinical trials establish biological effects, as well as safe dosages and pharmacokinetics...

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? - IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - 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 under the IND. - Form FDA 15...

What must you file before conducting human clinical trials with an experimental drug? - IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - 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 under the IND. - Form FDA 15...

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...

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 ...

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 ...

____ 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 ...