Physicians are using what type of medicine strategy to make treatment decisions? pg 303 - Evidence-based medicine strategies defined as a set of validity and usefulness criteria that physicians use to review studies and make treatment decisions What is the SHORT Call protocol? pg 303-305 - 1) Focus - focus on specific patient type and data that supports treating this patient type such as clinical evidence 2) Validity and Usefulness - statistical significant 3) Courageous Questions - compa...

NAPSRx Certification Exam Study Guide Chapter 15

Pharmaceuticals - medicines and vaccines for human and animal use. products may have a brand name or be generic, and they may be prescription or OTC Diagnostic - equipment and supplies used in screening, detecting, and monitoring disease. can range from simple home testing kits to sophisticated imaging technologies Medical devices - advanced instrumentation and appliances used for medical therapy, such as joint replacements, implantable defibrillators, and pacemakers. Also includes drug de...

The FDA regulates the introduction of new drugs and enforces U.S. drug laws. - True 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...

What are some of the elements of Good Laboratory Practices? - 1) Personnel must have the education, training, and experience to conduct nonclinical studies 2) A quality assurance unit should be measurable 3) Materials for studies must be appropriately tested for identity, strength, purity, stability and uniformity 4) Appropriate personnel, resources, facilities, equipment, materials, and methodologies must be available 5) Studies must be conducted under specifically designed protocols wit...

NAPSRx Certification Exam Study Guide Chapter 3

Most recent studies have estimated the cost of bringing a new drug to market is how much? - $1..5 - 1.8 billion For every 5,000-10,000 compounds that enter R&D, how about many are approved by the FDA? - 1 Why have many pharmaceutical R&D processes become longer and more complex? - more complex scientific tools and disease targets more intensive regulatory process growing demand in medical community for more complex data about pharmaceuticals What percent of costs associated with new drug...

NAPSRx Certification Exam Study Guide Chapter 16

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