Drug Development Test 1 Questions with 100% Correct Answers | Latest Version 2024 | Verified

Drug Development Test 1 Questions with 100% Correct Answers | Latest Version 2024 | Verified What is the objective of drug development? - To gain an overview of the drug development process which includes target identification, validation, assay development, manufacturing processes and regulatory oversight. What is the difference between the pharmacology definition of drugs and the federal definition? - The pharmacology definition states that a drug is chemical substance that is used in treatment, cure, prevention, or diagnosis of disease or that is used to enhance the physical or mental well being The federal government defines drugs as any substance found in any nation's pharmacopeia, any substance that is used in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals. It also includes anything other than food that is intended to affect the structure or any function of the body. Any substance that is used to make other drugs and habit forming or illicit substances. Also, any substance prepared and sold as pharmaceutical items, either by prescription or over the counter How has the definition of drugs changed? - It once included dyes or anything involved in chemistry or pharmacy. How does the FDA define drugs? - An article that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease, or to affect the structure or any function of the human body or other animals How will we be defining drugs in this class? - A medicinal substance or biologic that provides favorable therapeutic or prophylactic pharmaceutical benefits to the human body What are the three names associated with drugs? - Trade: Prilosec Generic: Omeprazole Chemical: 6-methoxy-2-((4-methoxy-3,5-dimethylpyridin-2-yl) methylsulfinyl)-1Hbenzo[d]imidazole What are a few ways to classify drugs? - Good v. Bad Agonists v. Antagonists Prescription Drugs v. OTC MOA Chemical Structure Organ/System they target Therapeutic effects How has drug development influenced medicine? - Most of current medicine is based on the use of drugs How have drugs influenced humanity? - Saved lives and increased life expectancy How difficult is it to get drugs to the market? - It takes about 15 years to bring a drug to market, spending around 1.0-1.2 billion dollars. Only about 1: 10000 will make it to market and 1:5 drugs that enter in clinical trials will move to the market. Pharm sales in 2006 643 billion, with half of those in the US. How long does a drug patent last? What does this mean? - 20 years, meaning that generic drugs cannot be made before then. Why is the pipeline drying? - The pipeline is drying due to an innovation deficit which is the result of an increased demand on safety. How much do pharm companies spend on R&D? - 20% or 40 billion Has the number of drugs introduced every year been decreasing or increasing? - Decreasing What is your goal by the time the patent expires? - To have earned more than what you spent on development of the drug. Has drug development changed over the course of human history? - Drug development has been a constant occurrence throughout human history but has improved vastly over the past century due to improved chemical discoveries, as well as the discoveries in molecular biology, recombinant DNA tech, genomics, proteomics, bioinformatics, lab equipment and automation. In what ways has there been an effort to make research more translational? - The NIH started the CTSA and pharm companies are always taking in graduate students What are the five steps in drug development? - Drug Discovery Drug Development Clinical Trials Manufacturing Marketing Application Describe the timeline for drug development. - Assessment of Target Expression 1. Localization and quantification of target Lead Compound Optimization 1. Characterization of Disease and Efficacy of Compound Pre-Phase 1 Studies 1. 3.8 years to this point Clinical Phase 1-3 1. 8.6 years FDA Approval