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.
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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
Power Calculation and Sample Size Estimation
- Parallel Design 255 KB (update 2021-07-05)
- 2×2×2 Design 205 KB (update 2021-07-09)
- 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 2021-07-10)
- 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 174 KB (update 2021-06-24)
- Two-Stage Designs
- Group sequential (fixed sample design) 🚧
- Adaptive (sample size re-estimation) 🃏 🚧
- Non-Inferiority 🚧
- Non-Superiority 🚧
Dose Proportionality 🚧
- Trapezoidal Rules 141 KB (update 2021-06-25)
- 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.