Ing. Helmut Schütz

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Articles

To the right articles are listed in chronological order. Below are articles ordered by topic.

• 🃏 Related to questions commonly asked by regulatory assessors.
• 🆕 Published within the last two weeks.
• 🚧 Article under construction.

To reproduce the articles’ examples is required.

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Power Calculation and Sample Size Estimation

Equivalence

• Parallel Design 246 KB (update 2021-08-08)
• 2×2×2 Design 217 KB (update 2021-10-24)
• Higher-Order Crossover Designs 207 KB (update 2021-07-10)
• Replicate Designs
  • Average Bioequivalence 165 KB (update 2021-04-01)
  • Scaled Average Bioequivalence
    • Highly Variable Drugs / Drug Products
      • RSABE (FDA, China’s CDE) 147 KB (update 2021-10-13)
      • ABEL (all others) 159 KB (update 2021-07-10)
    • Narrow Therapeutic Index Drugs (FDA) 🚧
    • Highly Variable Narrow Therapeutic Index Drugs (FDA) 🚧
  • ABE, RSABE, ABEL: A Comparison 235 KB (update 2021-10-08)
• Two-Stage Designs
  • Group sequential (fixed sample design) 🚧
  • Adaptive (sample size re-estimation) 🃏 🚧

Non-Inferiority, Non-Superiority

• Non-Inferiority 🚧
• Non-Superiority 🚧

Dose Proportionality 🚧

Prospective Power

• Power Analysis 52 KB (update 2021-10-13)
• Sensitivity Analysis 🚧

Noncompartmental Analysis

• Trapezoidal Rules 139 KB (update 2021-10-08)
• Estimation of λ_z 🚧
• Partial AUC 🚧
• Cut-off Times for Biphasic Release Products 🚧
• C_min and C_τ 🚧

Miscellaneous

Statistics

• A Short History of Bioequivalence 🚧
• Carryover – a Never Ending Story 103 KB (update 2021-05-11) 🃏
• Significant Treatment Effect 105 KB (update 2021-04-08) 🃏
• Group ‘Effect’: To Pool or Not to Pool? 🃏 🚧
• Post hoc Power 148 KB (update 2021-07-07) 🃏
• ‘Apparent’ Difference in t_max? 129 KB (update 2021-04-22)
• Inflation of the Type I Error in SABE 🚧
• Simulations 101 127 KB (update 2021-04-11)
• A Rant About ‘Nice Numbers’ 78 KB (update 2021-06-24)
• ‘Precise’ Numbers in Reports 🚧
• Subgroup Analyses 🚧
• Adjusted Indirect Comparisons 🚧

Design Issues

• Tricks and Traps of Washout Phases 🃏 🚧
• SABE planned based on the CV_w from a 2×2×2 Crossover Design 🚧
• Overall Power of Multiple Studies 🚧
• Stratified Randomization. Why? 🚧

Software

• The Wonderland of Representing Numbers in Computers 60 KB (update 2021-06-23)
• 🇷 on Windows 101 45 KB (update 2021-08-30)
• Software Validation 🚧

All articles are licensed under Creative Commons Attribution 4.0 Helmut Schütz 2021.