This series of articles was inspired by recurrent discussions at the Bioequivalence and Bioavailability Forum and questions I received from regulatory assessors or my clients.
The true Enlightenment thinker, the true rationalist,
never wants to talk anyone into anything.
No, he does not even want to convince;
all the time he is aware that he may be wrong.
– Karl R. Popper
To the right articles are listed in chronological order. Below are articles arranged 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.
since formulas will not be rendered. Furthermore, the TOC
in the left column for navigation will not be available and code-folding not supported. Sorry for the inconvenience.
Power Calculation and Sample Size Estimation
- 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 🚧
Dose Proportionality 🚧
- Trapezoidal Rules 139 KB (update 2021-10-08)
- Estimation of λz 🚧
- Partial AUC 🚧
- Cut-off Times for Biphasic Release Products 🚧
- Cmin and Cτ 🚧
- Tricks and Traps of Washout Phases 🃏 🚧
- SABE planned based on the CVw from a 2×2×2 Crossover Design 🚧
- Overall Power of Multiple Studies 🚧
- Stratified Randomization. Why? 🚧
Those people who think they know everything
are a great annoyance to those of us who do.
– Isaac Asimov
All articles are licensed under Creative Commons Attribution 4.0 Helmut Schütz 2021.