Fda time frames - Study guides, Class notes & Summaries

. Which of the following is a contraindication for use of oxytocin to induce labor? A. Missed abortion B. Placenta previa C. Hyperbilirubinemia D. Pregnancy past due date Answer: B. Placenta previa Use of oxytocin is contraindicated in the presence of placenta previa. Labor induction in this condition could be fatal to the fetus. Placenta previa is an indication for cesarean section. Specific contraindications to oxytocin include hypersensitivity to the hormone itself or any part of itss...

Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - CORRECT ANSWER-A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substances Act d) Kefauver-Harris Amendments (1:2) - CORRECT ANSWER-D: Kefauver-Harris Am...

recumbency The term for lying on the side is: On the bottom of the back feet The plantar part of the body is located: Rostral The term for toward the nose is: toward the tail The term caudal means: a Guinea pig A cavy is: Ovine A sheep is called: amphibian A frog is an example of a: not eating The term anorexia means: to create a new opening The suffix -stomy means: Urinary bladder The term cysto- refers to: True T/...

What type of application is required to start studying an investigation drug in humans - Correct Answer IND What is the difference between a commercial IND and non-commercial IND applications - Correct Answer commercial INDs are sibmmited by corporate netities or orgnaizations for commercialization non-commercial INDs are submitted by individual investigators for research or emergency purposes (i.e. to treat serious, lifethreatening diseases). three types of non commercial INDs: invest...

1. Which of the following is a contraindication for use of oxytocin to induce labor? A. Missed abortion B. Placenta previa C. Hyperbilirubinemia D. Pregnancy past due date Answer: B. Placenta previa Use of oxytocin is contraindicated in the presence of placenta previa. Labor induction in this condition could be fatal to the fetus. Placenta previa is an indication for cesarean section. Specific contraindications to oxytocin include hypersensitivity to the hormone itself or any part of its...

Drug Discovery - • Unlike small molecule drugs (pharmaceuticals), large molecule drugs (biopharmaceuticals) are mainly protein-based o These protein-based drugs are similar to natural biological compounds found in human body or they're fragments that mimic active part of natural compounds Discovery of Pharmaceuticals - commences w/ scanning hundreds of compounds, whether w/ actual materials (irrational approach) or virtual simulations (rational approach) • Pharmaceuticals are new che...

RAC Exam practice test bank 2023 all possible questions and answers with complete solution Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substance...

Question: The Confusion Assessment Methods Instrument (CAMI) is a … assessment tool for which of the following disorders? Question: Which of the following is a common sensory deficit of conversion disorder? Check all that apply. Question: Delirium is an example of which type of clinical problem in psychosomatic medicine? Question: All the following medications are … in the treatment of Parkinson’s disease dementia/psychosis EXCEPT for Question: Indicators of imitative dissociative iden...

Food Safety RegulationsFDA Food Code - correct answer Issued by the FDA based on the Conference for Food Protection (CFP) made up of reps. from the food industry, government, academia, and consumer groups. It outlines the federal government's recommendations for food safety regulations for the foodservice industry. FDA Code Guidelines - correct answer Food handling and preparation, Personnel, Equipment and utensils, Cleaning and sanitizing, Utilities and services, Construction and maintenanc...

IBWA CPO Exam Study Set - Chapter 5 Already Passed _______________________ of product provides the final safeguard of the water's quality Packaging Packaging includes these four procedures: - Handling of containers/closures - Sanitation of bottles and care of bottle washer - Filling containers - Coding bottles with date of production _______________ includes the handling of containers/closures, sanitation of bottles and care of bottle washer, filling containers, and coding bottles with date ...