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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Rubas, Werner, PhD
Business Name PK/ADME Consulting, LLC
Certifications
Education

Pharmacy Degree From School of Pharmacy ETH, Zurich, Switzerland

Ph.D. (Liposomal Delivery of ARA-C) from School of Pharmacy, ETH Zurich

Business Address 303 Twin Dolphin Drive
Redwood City, CA 94065
US
Contact information
Telephone:
Email address:
Specialties

Pharmacokinetics - in vitro to in vivo extrapolation, compartmental / non compartmental

Lead Optimization - screening paradigms / optimization, development plan

Entry into Human - Investigator brochure, IND, CTA, 

Data Analysis - interpretation and action plan

Modeling & Simulation - PBPK

PK / TK Study Protocols - protocol writing / review

Project Leader - Lead /  manage internal and external projects

Contract Research - identification of CRO, data management

Due diligence - review of in- or out licensing opportunities, present to VC firms or partner

Translations: English - German / German - English

Experience

PK/ADME Consulting has in depth experience  in  a variety  of therapeutic areas  and will be able to assist you with  all your pharmacokinetic drug development needs. The know-how spans the range from Lead Identification (LI), Lead Optimization (LO), Entry into Humans (EIH), Phase I and Phase II clinical studies. The expertise includes hands-on in vitro and in vivo study design and execution. PK/ADME Consulting can provide pharmacokinetic (non-compartmental and compartmental) and toxicokinetic analysis and data review. We are experienced in applying Physiologically Based Pharmacokinetic (PBPK) to predict human drug exposure. Furthermore, our experience includes small molecules and biologics (antibodies and proteins).

In the in vitro Pharmacokinetic area, PK/ADME Consulting provides expertise in interpretation and translation of in vitro metabolic stability data from microsomes and hepatocytes, metabolite identification (MIST), risk management of reactive metabolites, protein binding, transport studies, cytochrome inhibition and / or induction studies.

In the field of in vivo absorption, distribution, metabolism and elimination (ADME) studies PK/ADME Consulting is a specialist in study protocol design, data analysis and interpretation.

In the area of Pharmacokinetic Modeling and Simulation, PK/ADME Consulting applies PBPK to predict plasma exposure based on in vitro and in silico data.

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