Ing. Helmut Schütz
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- Recent Threads in the Forum
- Partial AUC
- RE: Tmax, ke and t1/2 in fully replicate design of HVD
- Handling of the missing data
- Latest version of ASEAN BABE GL
- Interesting Data from HVD study
- Power calculation from Partial replicate study
- Amendment in Protocol Approval by Ethics Committee
- Canada Outlier (>5% subjects)
- Approval from Independant EC
- Elementary question on HVD datasets
- Bibliographic application
- Clarification on HVD paper
- Linear or nonlinear pharmacokinetics of lymecyclin
- Accepting analytical batch
- Phoenix and Proc. Mixed BE results
News
EU-EMA 2013-02-13: Q & A document
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EMEA/FDA 2009-08-03: GCP Initiative
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Guidances
EU-EMA 2013-03-15 Draft guideline on modified release dosage forms
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EU-EMA 2012-09-14: Draft Guidelines on oral MR products and transdermal patches (Section I: Quality)
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US-FDA 2012-08-22: Draft Guidance on SelfIdentification of Generic Drug Facilities, Sites, and Organizations
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Can-HPFB 2012-08-21: Draft Guidance BCS Based Biowaiver
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Can-HPFB 2012-05-22: Comparative Bioavailability Studies.
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NIHS 2012-02-29: Revision of BE Guidelines
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US-FDA 2012-02-09: Draft Biosimilar Guidances
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EU-EMA 2011-11-17: Appendix IV to the BE Guideline
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EU-EMA 2010-01-29: Guideline on the Investigation of BE
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EU-EMA 2009-11-19: Bioanalytical Method Validation
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Consultancy Services for Bioequivalence and Bioavailability Studies
BEBAC specializes in providing biostatistical services, contractor selection and supervision. We have wide experience with bioanalytics, pharmacokinetics, and biostatistics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in planning and evaluation, responding deficiency letters, as well as preparation for regulatory hearings, placement 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 GLP certified laboratory information management system, holding 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 33 years and more than 500 BA/BE studies. For the past eight years he has been working to set up BEBAC.
Helmut Schütz is a member of the Drug Information Association (DIA), the International Pharmaceutical Federation (FIP), the International Society for Clinical Biostatistics (ISCB), the International Biometric Society (IBS), the European Network for Business and Industrial Statistics (ENBIS), the Austrian Pharmaceutical Association (ÖPhG), and the Austrian Association of Consulting Engineers (FI).
Next Presentations
5–6 June 2013, Leuven, Belgium
23–25 September 2013, Amman, Jordan
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: http://bebac.at/
F: http://forum.bebac.at/
document date 2011-05-13 | last update 2013-05-21
site opened 2004-07-26 | document date 2011-05-13 | last update 2013-05-21