Ing. Helmut Schütz
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- Recent Threads in the Forum
- FDA regulation on Overage of drug product
- Forced Degradation study of Hydrocortisone
- In-vitro equivalence
- FDA: In-Vitro Alcohol testing of modified release product
- Omeprazole
- Damn good breakfast if you ask me or looking for a free pass
- Sample Size from Interaction study
- How many calibration curve and how many day for precision
- Blinding in Canadian BE Study
- Withdrawal Criteria as per Canadian Guideline
- Several group design with unequal washout
- Parallel study as pilot for long half life drug
- How to use Loo Riegelman method and deconvolution
- Arbitrary (and unjustified) cut-off of r²
- Bioanalytical work - GLP still needed?
News
EU-EMA 2012-02-16: Q & A document
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EMEA/FDA 2009-08-03: GCP Initiative
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WHO 2008-04-25: BCS-Update.
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Highly Variable Drugs
US-FDA 2006-10-06: Meeting of the Advisory Committee for Pharmaceutical Sciences.
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Guidances
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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Can-HPFB 2010-01-25: Comparative Bioavailability Studies.
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EU-EMA 2009-11-19: Bioanalytical Method Validation
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EU-EMEA 2008-07-24: Revision of the Guideline on the Investigation of BE
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EU-EMEA 2007-10-18: Advice to Applicants / Sponsors / CROs of BE Studies.
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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 32 years and more than 500 BA/BE studies. For the past seven 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).
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 2012-04-12
site opened 2004-07-26 | document date 2011-05-13 | last update 2012-04-12