Ing. Helmut Schütz
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- Recent Threads in the Forum
- Non-aqueous solutions
- Russia: Changed procedure for determining drug interchangeability
- Pediatric study for a combination product
- Orange or citrus flavor
- ANVISA guidelines for two-stage design
- Clinicaltrials registration
- Route of administration other than oral for concomitant medication
- ANOVA MODEL
- Study which captures SD and SS PK Profiles
- Glycopyrrolate BCS Class
- EMA: What do I need if I want to run an overdose study
- Statistical evaluation and BE hypotheses in full replicate design
- Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission
- Higher-order crossovers
- FDA: required BE between early phase and Phase 3 formulations?
- What are we doing here?
- Sample size calculations
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FDA 2019-02-19 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs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FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product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, 26 February 2020 20:12 CET (Europe/Vienna; UTC +01:00)
Site opened 2004-07-26 | document date 2011-05-13 | last update 2020-02-18