Ing. Helmut Schütz
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- Recent Threads in the Forum
- Trinidad and Tobago Bio-equivalence guidelines
- Dose curve
- Dabigatran EMA - product-specific guide
- AUC <5% of TEST geometric mean AUC
- ANOVA fixed and random effects
- Bioavailability-Sample size
- In-vitro population bioequivalence
- In-vitro Population Bioequivalence
- Rules acc. to Health Canada
- Formulas to calculate sample size
- PK/PD Index
- Two different lot of RLD in 2WC steady state study due to short shelf-life
- Sample Size calculation for ophthalmic PK endpoint study
- LSMeans, still causing lots of people headaches
- Simulation plasma and tissue profile
- Ilat and dlat
- Ratio % in ABE vs. Point Estimate in RSABE
- Phoenix Winnonlin
- Can we have two primary objectives?
- Random calibration samples
News
EMA 2018-08-03 Product-specific guidances
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ICH 2018-06-27 Draft Guideline on BCS-based biowaivers
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FDA 2018-05-21 Guidance on Bioanalytical Method Validation
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FDA 2017-12-21 BCS-based Biowaivers
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FDA 2017-10-24 Drug-drug Interactions
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ICH 2016-10-07 Concept Papers on BCS- based biowaivers and bioanalytical method validation
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FDA 2016-12-21 ANDA Submissions ― Refuse-to-Receive Standards
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HPFB 2016-04-18 BE Standards for HVDPs
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EMA 2015-11-19 Q & A document
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EMA 2014-11-20 Guideline on MR dosage forms
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EMA 2014-10-23 Guideline on similar biological medicinal products
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FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
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FDA 2014-03-18 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs
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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 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 Austrian Pharmaceutical Association (ÖPhG), the European Network for Business and Industrial Statistics (ENBIS), and the Austrian Association of Consulting Engineers (FI).
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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 2019-02-11)
Accessed on Monday, 18 February 2019 15:30 CET (Europe/Vienna; UTC +01:00)
Site opened 2004-07-26 | document date 2011-05-13 | last update 2019-02-11