Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...

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3/15/13% Fairy Tale Three Stories Ethics Law Regulatory Brief History of Drug Development • Problem • “I have a headache” • Solution • 2000 BC- Here, eat this root • 1000 AD- That root is heathen, say this prayer • 1850 AD- That prayer is superstition, drink this potion • 1940 AD- That potion is snake oil, swallow this pill • 1950 AD- That pill is ineffective, take this prescription drug • 2010 AD- That drug is too expensive take this generic 2%
3/15/13% Medicinal “Nuts” • 67 y/o female with non-resectable carcinoma of the bowel ground up 12 bitter almonds given to her by friend to increase protein intake. Within 30 minutes she developed crampy abdominal pain and then collapsed. • VS – 128 20 138/90 afebrile • HEENT – PERRL 4 mm, unusual breath odor • Lungs – clear lung fields • Cor – Regular tachycardia without murmurs • Abd – occasional BS, soft and NT • ABG 7.17/CO 2 25/O 2 56 • Lactate 14 meq/L Shragg TA. West J Med 1982;136:65-69 What is the Toxin Cyanide 3%
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Page 5 and 6: 3/15/13% Hydroxocobalamin Drug Deve
Page 7 and 8: 3/15/13% Transition probabilities 1
Page 9 and 10: 3/15/13% Prescription Drug User Fee
Page 11 and 12: 3/15/13% Standards in Drug Developm
Page 13 and 14: 3/15/13% Marcie Edmonds, 52, was st
Page 15 and 16: 3/15/13% 25.0 National Health Expen
Page 17 and 18: 3/15/13% Dr. Gleason Promoted Xyrem
Page 19 and 20: 3/15/13% FDA’s Deputy Commissione
Page 21 and 22: 3/15/13% lipidrescue.squarespace.co
Page 23 and 24: 3/15/13% Phase II Failures: 2008-20
Page 25 and 26: 3/15/13% Hydroxocobalamin: Cost Ana

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