Pharmaceutical Industry: Drug Development, Approval, and Administration, Exams of Health sciences

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Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. True Average review time for a new drug 18 months Sales Team Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. True 3,070 new meds are in development for cancer. True Define Off-label Usage of a medication for purposes other than the specific ones appearing on the label Toxicity The extent, quality, or degree to which a substance is poisonous or harmful to the body

Institutional review Board (IRB) A committee of physicians, stasticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin. Placebo Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema Swelling Asymptomatic Without signs or symptoms Clinical Pharmacology The study of the effects and movement of drugs in the human body Anatomy The study of basic structures of the body Physiology The study of how those body structures function Basic clinical pharmacology involves 3 main concepts Pharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics Study of the biochemical and physiological effects of drugs and their mechanisms of action i.e. the study of what a drug does to the body. It describes the therapeutic effects of drugs (pain relief, blood pressure reduction, their side effects and their sites of action.

Pharmacokinetics Study of how a drug is processed by the body, with emphasis on the time required for absorption, duration of action, distribution, and method of excretion. The study of how the body affects drugs. Drug distribution & elimination Drug delivery systems, route of administration , modes of excretion. Plasma The liquid portion of the blood that carries proteins and other substances Organs Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin) Nucleus Brain of the cell that regulates all activities. Proteins A nutrient made up of of chains of amino acids Fats A nutrient stored in special body tissues as a great source of reserve energy Carbohydrates A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. Vitamins

A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body. Minerals A nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient True Body's Major Systems Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune Absorption How the drug passes from its side of administration into the bloodstream Distribution How the drug is dispersed among the organs after absorption into the blood Metabolism How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Excretion How the drug is eliminated from the body. Usually drugs are eliminated via urine. They can also be excreted through the lungs, skin, or breast milk. It takes about 10 years for a drug to hit the market True Routes of drug administration Pg 26- 29

Seven rights of drug administration pg 30 Bioavailability how quickly and how much of a drug reaches its intended target site of action Bioequivalent when they contain the same active ingredients and proceed virtually the same blood levels over time. Therapeutic equivalence Production of the same medicinal effect Drug elimination and Excretion pg 34 Drug Forms Pg 35- 38 Patent last 20 years True Inactive ingredients

Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body Pharmaceutical Ingredients Pg 54 BID twice a day Cmax Peak plasma concentration on a measuring curve Half-life Period of time it takes for a specific amount of drug in the body to be reduced, through the excretion or elimination process, to exactly one-half that original amount PRN As needed QD Once a day QID Four times a day

Protein binding the ability of certain drugs to bind to plasma protein. TID three times a day Titration the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects Tmax Time of peak plasma concentration on a measuring curve STAT Immediately Primary wholesale distributors Buy most of their drugs directly from manufacturers. Legally considered authorized distributors within the meaning of the PDMA because they usually have ongoing relationships with manufacturers Secondary wholesale distributors Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered authorized distributors of the manufacturers within the meaning of the PDMA

Distribution Terminology Pg 60- 61 Average wholesale price (AWP) Published wholesale price of list price suggested by the manufacturer. Chain drug store Company that owns and operates four or more pharmacies Drop shipment Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler Group purchasing organization (GPO) An entity consisting of two or more hospitals or other healthcare entities that is formed to offer its members access to purchasing contracts for health supplies Upcharge Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution Package Insert Info Pg 63 Drug Patents

Pg 65 Terms pg 67 Orange Book ratings A AA AN AO AP AT B Hatch-Waxman Act aka Drug Price Competition and Patent Term Restoration Act of 1984. Considered the most significant drug-related legislation affecting pharma and healthcare. H-W made it easier to bring generics to the marker by requiring FDA to only look at bioavailability studies in order to approve. Also gave protection to the research based manu's by providing a 30 months automatic cooling off period It is important not to change the order of a sample closet True Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples True Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically.

True Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be subjected to extremes of temperature, moisture, and contamination True A sample closet or cabinet is essentially similar to a grocery store shelf. The more visibility you can give your drug, the more likely it will be used. True In some situations, a physician may sign the paperwork before the number of samples has been recorded True Section 503 Prohibits sale, purchase, or trade of drug samples E-sampling Pg 72 Many pharmaceutical manufacturers set expiration dates every six months (June, December) True DEA regulates the distribution and use of narcotics and other controlled substances

True FTC Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior AMA provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies Benefits of Government-Industry Partnerhsips Pg 79 Preclinical studies pg 81 Pinocytosis Involves the engulfing of fluids by a cell. Transport Mechanisms Passive diffusion, facilitated diffusion, active transport, pinocytosis Absorption methods Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous

The liver is the major organ for metabolizing drugs. Secondary is kidney True CL= rate of drug elimination/drug concentration in blood True In vitro assays are increasingly being see because they are usually less expensive, offer more rapid results, and are not as prone to negative publicity. True Clinical Trials pg 89 Subjects should be informed about the aims, methods, risks, and benefits of the trial True Four phases of clinical trials Pg 90 Regulatory Requirement terms Pg 92

Investigator The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor Sponsor The organization or individual that initiates the trial and finances the study, Protocol This document sets out how a trial is to be conducted Epidemiology The study of how factors influence disease and health in human populations. Therapeutic Antibodies Vaccines Pg 108 Toxoids Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines. Vector-based vaccines Viruses and bacteria are detoxified and used as vehicles to carry vaccines. Example is the use of canary pox (a virus that infects birds but not humans) to carry envelope proteins for HIV treatment