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CNPR Certification

Chapter 3

Pharmaceutical companies are generally _______ or ________. research-based, focused on manufacturing generic drugs.
Ethical Pharmaceutical Company Companies that develop branded drugs that are sufficiently novel to protected by patent from imitators.
What are the 3 major activities of a full-service pharmaceutical company? 1)Research & Development 2)Manufacturing & Operations 3)Marketing & Sales
Research & Development The "engine of innovation," focused on discovering or inventing promising new chemical or molecules and transforming them into safe and effective products.
Manufacturing & Operations supply chain, manufacturing, trade, and distribution of the business.
Marketing & Sales Communication of benefits of the products and create demand for those products using programs to influence physicians, pharmacists, payers, consumers, and other stakeholders.
Managed Markets group Responsible for outreach to large corporate accounts and managed care organizations.
How many new drugs were approved by the FDA in 2012? 39
How many new drugs does the European Medicines Agency expect to approve in 2013? 54
Internationally, _____ new drugs are expected to be approved every year. 100+
PhRMA reports that over _____ medicines are currently in development. 5000
______ of the 5000 medicines currently in development are in the U.S. 3400
The Pharm industry directly employs ______ people. 650,000
The pharm industry indirectly supports approx. ___________ million jobs in other sectors. 4 million
Since 1890, the average lifespan of an American has increased by ______ years. 30
Since 1950, the average lifespan of an American has increased by 10 years from ____ to ____. 68.2, 78.7
Since 2009, life expectancy has risen ______ years for males and ____ years for females. 1.9, 1.6
The increased life expectancy in the US has created net economic gains for Americans of over ___ trillion, more than ____ percent of the gross domestic product. 2.4, 20
In 2012, US biopharmaceutical companies accounted for ___ of the sectors global R&D expenditures and is expected to increase 74%
What is the key reason for R&D investment transfer form Europe to the US? Price Controls
What is a R&D Approvable letter? Letter sent by FDA to applicant that New Drug Application or Abbreviated New Drug Application for a product substantially meets the necessary requirements and whether or not the agency believes it can approve the application if specific changes are made.
What is R&D Asymptomatic? Without signs or symptoms of disease.
What is a blinded or masked study? A study where the participants do not know if they are in the experimental or control group.
What is a control group? The standard by which experimental observations are evaluated.
What are participants in the control group given? Standard treatment and/or placebo.
What is a double-blind or double-masked study? Neither the participants OR the staff know which participants are getting the experimental drug and which are the control group.
What is Edema? Swelling
What are Fast-Track Drugs? Fast-Track approval is provided for drugs that meet medical needs for pat9ients with serious or life-threatening conditions.
What is Indication? In drug approval, the exact cause or purpose for which the FDA has approved that a drug can be prescribed.
What is an IRB? Institutional Review Board
What does the IRB do? Committee of physicians, staticians, and community advocates and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All studies in the US must be approved by an IRB.
What is an Off Label use? Usage of a medication for purposes other than the specific ones appearing in the labeling.
What is a placebo? Inactive pill, liquid, or powder that has no treatment value. Used in clinical trials to compare results of experimental drugs.
What is Placebo Effect? The effect produced by a placebo due to the expectations of the patient. Generally measured by comparing the effect observed in patients receiving the placebo treatment to the effect observed in patients receiving the active treatment.
What is Study Protocol? The general design and operating features of a trial. More general than the study manual which includes day to day execution of the trial.
What is Toxicity? The extent, quality, or degree to which a substance is poisonous or harmful to the body.
What is a Treatment Group? A group of patients assigned to receive a specified treatment.
Created by: dgvoss