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- In-vitro Population Bioequivalence (PBE) Parameters for Particle Size Distribution (PSD) balakotu 2024-01-06 13:23 [🇷 for BE/BA]
- FDA: PD BE study balakotu 2023-07-12 06:24 [Power / Sample Size]
- Data analysis and sample size for replicate study designs as per recent FDA guidance balakotu 2023-05-23 14:16 [Regulatives / Guidelines]
- Center term in Bioequivalence Study balakotu 2022-06-08 10:03 [Study Assessment]
- Adjusting weight to reflect group differences in Model balakotu 2022-03-29 13:24 [General Statistics]
- Langmuirs Plots – Equilibrium Binding Studies balakotu 2022-02-17 14:23 [Software]
- balakotu 2019-06-21 09:31 [Regulatives / Guidelines]
- Dose term in the ANOVA Model balakotu 2019-06-18 15:03 [Regulatives / Guidelines]
- Population Bioequivalence (PBE) analysis for in-vitro studies balakotu 2019-05-22 09:41 [Regulatives / Guidelines]
- Replicate Study design for Brazil balakotu 2018-05-21 15:31 [Regulatives / Guidelines]
- Marginally failed study for Europe balakotu 2018-04-24 09:30 [Study Assessment]
- balakotu 2018-04-13 10:22 [Design Issues]
- balakotu 2018-04-13 09:15 [Power / Sample Size]
- balakotu 2018-04-13 08:40 [Regulatives / Guidelines]
- balakotu 2018-04-12 17:01 [Regulatives / Guidelines]
- Full replicate designed study for Europe balakotu 2018-03-31 13:59 [RSABE / ABEL]
- HVDP for Health Canada balakotu 2017-03-21 13:16 [Regulatives / Guidelines]
- Sample size for Clinical endpoint BE studies balakotu 2015-12-15 13:28 [Software]
- Mesalazine tablets for Europe Market balakotu 2015-10-19 11:47 [RSABE / ABEL]
- Power Calculation for Replicate study designs balakotu 2015-09-24 13:55 [Power / Sample Size]
- BA/BE Studies for Early Termination balakotu 2015-09-22 15:05 [Two-Stage / GS Designs]
- Sample size for Clinical endpoint BE studies balakotu 2015-08-20 11:34 [Regulatives / Guidelines]
- HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 11:05 [Regulatives / Guidelines]
- Bioanalysis balakotu 2014-11-28 09:26 [Regulatives / Guidelines]
- WinNonlin (MD simulation from SD data) balakotu 2014-10-14 16:00 [Software]
- balakotu 2014-07-05 13:42 [Regulatives / Guidelines]
- Nevirapine ER tablets balakotu 2014-07-02 10:50 [Regulatives / Guidelines]
- Esomeprazole GR Capsules balakotu 2014-06-27 14:24 [Regulatives / Guidelines]
- Regulatives Submission Issues balakotu 2014-05-19 16:06 [Study Assessment]
- regulatory requirement for Injection products balakotu 2014-03-18 08:34 [Regulatives / Guidelines]
- Population Bioequivalence for In Vitro Data balakotu 2014-01-15 08:02 [Regulatives / Guidelines]
- Replicate balakotu 2014-01-08 11:27 [Outliers]
- Replicate Study designs balakotu 2014-01-08 09:14 [Outliers]
- Study acceptance by US Regulatory balakotu 2013-06-19 16:36 [Regulatives / Guidelines]
- Partial replicate for USA balakotu 2013-01-10 09:37 [RSABE / ABEL]
- Replicate study design for Brazil submission balakotu 2012-11-14 10:49 [Regulatives / Guidelines]
- bioequivalence criterion for Levothyroxine balakotu 2012-07-31 15:57 [Regulatives / Guidelines]
- Replicate Study Designs balakotu 2012-07-09 11:16 [Design Issues]
- 2-Stage design balakotu 2012-06-21 10:28 [Two-Stage / GS Designs]
- Two-stage design approach balakotu 2012-06-20 09:18 [Two-Stage / GS Designs]
Ing. Helmut Schütz