Ing. Helmut Schütz

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 🚧

document date 2021-03-12 | last update 2021-04-18