Ing. Helmut Schütz
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- Recent Threads in the Forum
- SAS for PK analysis
- Doubts regarding IS variation, ISR failure & SEL/SPE Acceptance criteria
- Biowaiver for Emusion Dosage Form
- Comparative PK
- Inter subject CV to intra subject CV
- ICH E6, r3
- Fully Replicate Study
- Additional Group in Bioequivalence Study
- Reference datasets for 4x4 Williams’ design
- Missing three consecutive samples in the elimination phase
- Mean IS Variability consideration for Endogenous molecule-Stripped Matrix or BSA
- Retention samples
- Cataplasms and study design
- WHO guideline on data integrity
- ICH GCP type of the data
- New software for PK analysis - PKMP. Any good ?
- Exclusion due to adverse event
- BE study designing related doubts
- Regulatory Submission in Europe in Absence of Reference product
- Why is just Cmax out of specification?
Recent Articles
Power, Sample Size
Equivalence (ABE)
Higher-Order Crossover Designs
Highly Variable Drugs / Drug Products
Reference-Scaled Average Bioequivalence
Average Bioequivalence with Expanding Limits
ABE, RSABE, ABEL: A Comparison
Prospective Power
Noncompartmental Analysis
Miscellaneous
Carryover – a Neverending Story
‘Apparent’ Difference in tmax?
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 comparative bioavailability 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 forty 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).
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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 [email protected]
W https://bebac.at/
F https://forum.bebac.at/
Document date 2011-05-13 (last update 2021-05-03)
Accessed on Friday, 14 May 2021 03:48 CEST (Europe/Vienna; UTC +02:00)
Site opened 2004-07-26 | document date 2011-05-13 | last update 2021-05-03