Regulatory issues and Population simulations

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Changes in Prescribing Shift away from best practice prescribing e.g., amoxicillin for otitis media and sinusitis Decrease in prescription share of amoxacillin/clavulanate: 13.8 8.6% Increase in prescription share particularly of macrolides * , tetracyclines, cephalexin and cefaclor * Roxithromycin and erythromycin Beilby J, et al. Clin Infect Dis. 2002;34:55–64.
Changes in Outcomes Amoxicillin/clavulanate use shifted to sicker patients (decreased use for sinusitis) Increased cost of care Management became more conservative: • More radiologic (P=0.00001) investigations • More pathologic (P=0.005) investigations More hospitalizations (P=0.005) ? conservatism, ? therapeutic failures Beilby J, et al. Clin Infect Dis. 2002;34:55–64.
Page 1 and 2: Population-based approaches: Regula
Page 3 and 4: “High use” “Low use” Lancet
Page 5 and 6: Regulatory issues Regulatory agents
Page 7 and 8: Historical Evidence of Sensitivity
Page 9 and 10: Consequence to Patients If accept a
Page 11 and 12: Regulatory issues “Non-inferiorit
Page 13 and 14: Pneumonia Outcomes Research Team (P
Page 15 and 16: Fine MJ, et al. N Engl J Med 1997;
Page 17 and 18: PORT study Pneumonia Severity Index
Page 19 and 20: Patient Stratification in Acute Oti
Page 21 and 22: Effect of Age on Outcome of AOM Num
Page 23 and 24: Sample sizes required to detect dif
Page 25 and 26: Effect of study design on comparati
Page 27 and 28: Patient Stratification in Acute Exa
Page 29 and 30: Antibiotics in AECB 362 exacerbatio
Page 31 and 32: Antibiotics in AECB Results 80 p
Page 33 and 34: Stratification Based on Patient Cha
Page 35: Consequences of Inappropriate Guide
Page 39 and 40: Summary: A Natural Experiment in Au
Page 41 and 42: Population pharmacokinetics: exampl
Page 43 and 44: Monte Carlo Simulation 2 Monte Carl
Page 45 and 46: AUC values in acutely ill patients
Page 47 and 48: AUC values in acutely ill patients
Page 49 and 50: Monte Carlo Simulation of Distribut
Page 51 and 52: Probability of Achieving Target AUC
Page 54 and 55: Using PK/PD parameters to develop s
Page 56 and 57: Pharmacodynamic breakpoints for ora
Page 58 and 59: Susceptibility of US Isolates at PK
Page 60 and 61: Antimicrobial Recommendations for A

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