Ing. Helmut Schütz

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Articles

To the right articles are listed in chronological order. Below are articles ordered by topic (ones marked with ■ deal with questions commonly asked by regulatory assessors).

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Power Calculation and Sample Size Estimation

Equivalence

• Parallel Design
• 2×2×2 Design
• Higher-Order Crossover Designs
• Replicate Designs
  • Average Bioequivalence
  • Scaled Average Bioequivalence
    • Highly Variable Drugs / Drug Products
      • RSABE (FDA, China’s CDE)
      • ABEL (all others)
    • Narrow Therapeutic Index Drugs (FDA) 🚧
    • Highly Variable Narrow Therapeutic Index Drugs (FDA) 🚧
  • ABE, RSABE, ABEL: A Comparison 🚧
• Two-Stage Designs
  • Group sequential (classical) 🚧
  • Adaptive (sample size re-estimation) 🚧

Non-Inferiority, Non-Superiority

• Non-Inferiority 🚧
• Non-Superiority 🚧

Dose Proportionality 🚧

Prospective Power

• Power Analysis 🚧
• Sensitivity Analysis 🚧

Noncompartmental Analysis

• Trapezoidal Rules
• Estimation of λ_z 🚧
• Partial AUC 🚧
• Cut-off Times for Biphasic Release Products 🚧
• C_min and C_τ 🚧

Miscellaneous

• Post hoc Power ■ 🚧
• To Pool or Not to Pool? ■ 🚧
• Inflation of the Type I Error in SABE 🚧
• Carryover – a Never Ending Story ■
• R on Windows 101
• Software Validation 🚧
• Carryover – a Never Ending Story ■
• Tricks and Traps of Washout Phases ■ 🚧
• ‘Apparent’ Difference in t_max? 🚧
• Overall Power of Multiple Studies 🚧
• SABE planned based on the CV_w from a 2×2×2 Crossover Design 🚧
• Simulations 101
• The Wonderland of Representing Numbers in Computers
• ‘Precise’ Numbers in Reports 🚧
• A Rant About ‘Nice Numbers’
• Subgroup Analyses 🚧
• Stratified Randomization. Why? 🚧
• Adjusted Indirect Comparisons 🚧