Ing. Helmut Schütz
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- Recent Threads in the Forum
- Tegaserod analytical method
- Claim of Categorical Exclusion (21 CFR)
- Bonferroni and Bartlet's tests
- Clinical trials in Corona (Covid-19) time.
- Meets primary objective but not secondary objective
- Protocol amendment that may trigger Group effect test
- Impact of COVID-19 on HV trials
- Dextromethorphan
- Dissolution and bracketing - EMA
- RLD batch number in fed and fast studies
- USFDA Upper bound Criteria using R Software
- MR generic application
- What is meant by data amenable?
- Bioequivalence Study without approved/marketed or no RLD
- Comp in-vitro disso studies for generics in India
- Underrepresentation of female subjects in BE study to register Generic
- Rejection of the standard curve
Guideline Updates
ICH 2019-11-20 Guideline on BCS-based biowaivers
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ICH 2019-02-26 Draft guideline bioanalytical method validation
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FDA 2019-02-19 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs
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EMA 2018-08-03 Product-specific guidances
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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FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
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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 2020-02-18)
Accessed on Wednesday, 8 April 2020 14:30 CEST (Europe/Vienna; UTC +02:00)
Site opened 2004-07-26 | document date 2011-05-13 | last update 2020-02-18