NAPSR UPDATED CORRECT ANSWERS 100%

NAPSR UPDATED CORRECT ANSWERS 100%-research-based companies -leading edge innovator -develop branded drugs which are patented and protected from imitators ethical pharmaceutical companies the engine of innovation for big companies -focuses on discovering, inventing promising new chemicals or molecules and transforming them into safe and effective pharm products Research an Development this part of the company: -includes the supply chain, manufacturing, trade and distribution. -personnel package and produce the drug product and make it available for the public manufacturing and operations in 2012, the FDA approved _____ new drugs for use in the US, the highest number since 1996 39 New Drugs: -2 treatments approved for ________ -anti-viral -the virus affects 180 million people -leads to liver cirrhosis, cancer, death -only 2 of 66 medicines in development -potential to eliminate virus Hepatitis C New Drugs: -this approach considers individual patients unique molecular and genetic profiles when preventing, diagnosing, treating diseases -3 such drugs where approved in 2011, 2012 -12-15% of pharmaceutical companies are developing this kind of medicine Personalized Medicine New Drugs: -new drugs for which no medicines are available for -Bone disease for which there are currently no approved medicines Drugs for Hyposphtasia New Drugs: -only one other drug available for this disease (2011), this drug only slows the deterioration -disease causes progressive neurodegeneration in 20,000-30,000 people per year -leads to death and paralysis -new drugs have the potential to completely halt degeneration Lou Gehrig's Disease (ALS) New Drugs: -125 new treatments are in development -6th leading cause of death in the US, expected to rise with baby boomers growing older Alzheimer's Disease Drugs According to The Biopharmaceutical Pipeline, medicines that merely _________ could save $447 billion in 2050 delay the onset of disease New Drugs: 3,070 new drugs in development for this -WHO predicts that it will cause 13.1 deaths in 2030 -158 medicines for ovarian, 28 for cervical, 41 for small cell lung cancer New Cancer Drugs Accourding to PhRMA's 2013 Industry Profile, the pharmaceutical sector is the largest funder of bsuiness _______ in the US. It is estimated that they spend 48.5 million in 2012 and over half a trillion since 2000 Business R&D since 1890, the average lifespan of an American has increased by nearly ____ years 30 years in 2012, biopharmaceutical companies accounted for _____% of the sectors global R&D expenditures, and this number continues to rise 74% why has there been a shift of R&D from Europe to the US in recent years? Most European governments control the prices of medicines -this weakens their pharmaceutical industries and causes shifts outside their borders letters sent by the FDA to the applicant indicating whether the new drug application (NDA) or abbreviated new drug application (ANDA) for product substantially meets the necessary requirements and whether or not the agency believes that it can approve the application or abbreviated application specific additional information or material is submitted or specific conditions (i.e. certain labeling_ are agreed to by the applicant. Approval letters without signs or symptoms of the disease Asymptomatic a study in which participants do not know whether they are in the experimental or control group in a research study. Those in the experimental group get the medications or treatments being tested, while those in the control group get standard treatment for the illness or a placebo Blinded or Masked Study the standard by which experimental observations are evaluated. in many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo Control or Control Group a double-blind or double-masked study is one in which neither the participants nor the study staff know which participants are receiving the experimental treatment and which patients are in the control group. These studies are preformed so that neither patient nor doctor have expectations about the experimental drugs can influence the outcome Double-Blind or Double Masked Study Swelling Edema Fast-track approval is provided for drugs that meet medical needs for patients with serious or life-threatening conditions Fast-Track Drugs in terms of drug approval, the exact cause or purpose for which the FDA has approved that a drug can be prescribed Indication a committee of physicians, statisticians, community advocated, and others which ensures that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials in the US must be approved by an IRB before they begin Institutional Review Board (IRB) Usage of a medication for purposes other than the specific ones appearing in the label Off Label inactive pill, liquid or powder that has no treatment value. in clinical trials, experimental treatments are often compared with placebos to assess the treatments effectiveness Placebo the effect produced by a placebo due to the expectations of the patient. The effect in placebo-controlled clinical trials is generally measured by comparing of the effect observed in patients receiving the placebo treatment to the effect observed in patients receiving the active treatment. Placebo Effect the general design and operating features of a trial. it is distinguished from the study manual of operations by its generality and absence of specific details needed for day-to-day execution of the trail Study Protocol the extent, quality, or degree to which a substance is poisonous or harmful to the body toxicity a group of patients assigned to receive a specific treatment. Treatment Group