Ing. Helmut Schütz
directly to content (skip navigation)
- Recent Threads in the Forum
- Major metabolite fortification
- REML, ML and MM different BE decision
- Indirect adjusted comparisons in BE
- Possible reasons for group effect
- BSC approach at each strength?
- FDA: Date when a product is designated as RS (or RLD)
- Spreadsheet failures, any recent examples?
- Reproducibility of data analysis and reporting with R…
- Statistical comparison of dissolution profiles - variable nr of units
- One fail and one success, should it be accepted?
- Updates of installation bear with macOS (Mojave)
- Steady State achievement
- European Bioanalysis Forum: ICH M10 Workshop
- BioBridges 2019 – invitation & preliminary program
- Baseline sampling
News
ICH 2019-02-26 Draft guideline bioanalytical method validation
► read more…
FDA 2019-02-19 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs
► read more…
EMA 2018-08-03 Product-specific guidances
► read more…
ICH 2018-06-27 Draft Guideline on BCS-based biowaivers
► read more…
FDA 2018-05-21 Guidance on Bioanalytical Method Validation
► read more…
FDA 2017-12-21 BCS-based Biowaivers
► read more…
FDA 2017-10-24 Drug-drug Interactions
► read more…
ICH 2016-10-07 Concept Papers on BCS- based biowaivers and bioanalytical method validation
► read more…
FDA 2016-12-21 ANDA Submissions ― Refuse-to-Receive Standards
► read more…
HPFB 2016-04-18 BE Standards for HVDPs
► read more…
EMA 2015-11-19 Q & A document
► read more…
EMA 2014-11-20 Guideline on MR dosage forms
► read more…
EMA 2014-10-23 Guideline on similar biological medicinal products
► read more…
FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
► read more…
Consultancy Services for Bioequivalence and Bioavailability Studies
BEBAC specializes in providing biostatistical services, contractor selection and supervision. We have wide experience with biostatistics, pharmacokinetics, and bioanalytics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in designing and evaluating studies, responding deficiency letters, as well as in the preparation for regulatory hearings, assessment and evaluation of CROs.
Helmut Schütz studied Chemical Engineering in Vienna and is an independent consultant in the domain of bioavailability and bioequivalence studies.
Mr Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GALP-certified LIMS and held senior management positions, most recently as the head of a biostatistical department.
He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 39 years and more than 600 BA/BE studies.
Helmut Schütz is a member of the International Pharmaceutical Federation (FIP), the European Federation for Pharmaceutical Sciences (EUFEPS), the American Association of Pharmaceutical Scientists (AAPS), the International Biometric Society (IBS), the Association for Applied Human Pharmacology (AGAH), the Austrian Pharmaceutical Association (ÖPhG), the European Network for Business and Industrial Statistics (ENBIS), and the Austrian Association of Consulting Engineers (FI).
Short CVOut of office dates
| July | August | September | October | ||||||||||||||||
| M | T | W | T | F | M | T | W | T | F | M | T | W | T | F | M | T | W | T | F |
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | ||||
| 8 | 9 | 10 | 11 | 12 | 5 | 6 | 7 | 8 | 9 | 9 | 10 | 11 | 12 | 13 | 7 | 8 | 9 | 10 | 11 |
| 15 | 16 | 17 | 18 | 19 | 12 | 13 | 14 | 15 | 16 | 16 | 17 | 18 | 19 | 20 | 14 | 15 | 16 | 17 | 18 |
| 22 | 23 | 24 | 25 | 26 | 19 | 20 | 21 | 22 | 23 | 23 | 24 | 25 | 26 | 27 | 21 | 22 | 23 | 24 | 25 |
| 29 | 30 | 31 | 26 | 27 | 28 | 29 | 30 | 30 | 28 | 29 | 30 | 31 | |||||||
BEBAC – Consultancy Services for
Bioequivalence and Bioavailability Studies
Ing. Helmut Schütz
Neubaugasse 36/1/11
1070 Vienna, Austria
T +43 (0)1 2311746
M +43 (0)699 10792458
E office@bebac.at
W https://bebac.at/
F https://forum.bebac.at/
Document date 2011-05-13 (last update 2019-07-05)
Accessed on Monday, 22 July 2019 20:38 CEST (Europe/Vienna; UTC +02:00)
Site opened 2004-07-26 | document date 2011-05-13 | last update 2019-07-05