New chemical entity nce Study guides, Class notes & Summaries

RAC Prep Drugs with Latest Questions and Expert Answers drug ANSWER An article intended for use in the diagnosis, cure mitigation treatment or prevention of disease in man new drug ANSWER -New use of a drug substance or component (active ingredient, excipient, carrier, coating). -New use of a combination of approved drugs -Change in proportion of ingredients in a combination drug -New intended use of a drug -Change in dosage, method or duration of administration or application activ...

1. Question The name selected by the original manufacturer based on the chemical structure of the drug is the: A. Chemical name B. Drug name C. Generic name D. Trade name - Correct Answer: C. Generic name The generic name is the name of the active ingredient. The generic name is granted by the USAN Council and is commonly used to identify a drug during its useful clinical lifetime. Each medicine has an approved name called the generic name. A group of medicines that have similar ac...

drug - An article intended for use in the diagnosis, cure mitigation treatment or prevention of disease in man new drug - -New use of a drug substance or component (active ingredient, excipient, carrier, coating). -New use of a combination of approved drugs -Change in proportion of ingredients in a combination drug -New intended use of a drug -Change in dosage, method or duration of administration or application active moiety - Central, active part of a molecule or ion responsible for th...

NU 309 Module 1 Test Questions With Correct Answers pharmacology - ANSWER- study of the effects of drugs and chemicals on living organisms (where a drug can be broadly defined as any chemical substance, natural or synthetic, that affects a biological system) Key components of clinical pharmacology - ANSWER- drug's effects on the body body's response to the drug pharmakokinetics - ANSWER- refers to the absorption, distribution, metabolism, and excretion of drugs (body's response to...

NU 309 Module 1 Test Questions With Correct Answers pharmacology - ANSWER- study of the effects of drugs and chemicals on living organisms (where a drug can be broadly defined as any chemical substance, natural or synthetic, that affects a biological system) Key components of clinical pharmacology - ANSWER- drug's effects on the body body's response to the drug pharmakokinetics - ANSWER- refers to the absorption, distribution, metabolism, and excretion of drugs (body's response to t...

NU 309 Module 1 Questions with Correct Answers pharmacology - Answer-study of the effects of drugs and chemicals on living organisms (where a drug can be broadly defined as any chemical substance, natural or synthetic, that affects a biological system) Key components of clinical pharmacology - Answer-drug's effects on the body body's response to the drug pharmakokinetics - Answer-refers to the absorption, distribution, metabolism, and excretion of drugs (body's response to the drug...

Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy and have been published in peer-reviewed journa...

NU 309 Module 1 Test Questions With Correct Answers pharmacology - ANSWER- study of the effects of drugs and chemicals on living organisms (where a drug can be broadly defined as any chemical substance, natural or synthetic, that affects a biological system) Key components of clinical pharmacology - ANSWER- drug's effects on the body body's response to the drug pharmakokinetics - ANSWER- refers to the absorption, distribution, metabolism, and excretion of drugs (body's response to...

PCOL 355 Exam 1 Questions with Correct A What is the word for materials added to a drug formulary to help maintain the stability of the drug? - Answer-Excipients (ex: plasticizes) Name the 5 forms of injection drugs and their corresponding depth. - Answer-1. Intramuscular (IM)- muscle 2.Subcutaneous (SQ)- subcutaneous 3.Intravenous (IV)- dermis 4.Intradermal (ID)- epidermis 5.Microneedles- dermis+epidermis Describe the pathway of drug development from drug discovery to the market? (...

RAC Practice Exam 1 Questions and Answers New Version 2023 Complete Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic reco...