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BIOKINET [logo] GmbH

BIOPHARMACEUTICAL AND PHARMACOKINETIC STUDIES


Biokinet GmbH located in Vienna / Austria, has successfully performed more than 500 studies since 1983.

BIOKINET chemisches Laboratorium GmbH
Prinz-Eugen-Straße 6/6
1040 Vienna
tel +43(0)1 4856969
fax +43(0)1 9663804
mob +43(0)699 1947486
veit.nitsche@chello.at

RESPONSIBILITIES

Head of institute Veit Nitsche, PhD (veit.nitsche@chello.at)

BIOAVAILABILITY / BIOEQUIVALENCE

Absolut / relativ
Single dose / multiple dose
Interactions
Studies in steady state
In conformity with GLP, GCP, CPMP, ICH
Pharmacodynamic measurements
Large pool of volunteers
Special populations (e.g., postmenopausal females)
Phenotyped subjects
Independent ethics committee
Inhouse clinical department
Validated evaluation software (WinNonlin, StatXact, EquivTest, BIOEQV80, Statistica)

PHARMACOKINETICS
in man, animals

Absorption
Distribution
Biotransformation
Excretion
Estimation of pharmacokinetic parameters / simulations (WinNonlin, WinSAAM, Boomer, TopFit)
Calculation of optimal dosage regimens

ANALYTICS

GC
GC/MS
HPLC
LC/MS
RIA
Enzyme-immunological test procedures
Methods development
Contract analytics
Validation (according to FDA-Standards)
Validated LIMS (LAB/UX)
GLP certified since 1992
Current certificate (14 Jul 2003) GLP OECD/EU issued by the Austrian Ministry of Health

CLINICAL TRIALS

In conformity with GCP/CPMP/ICH
Monitoring
Audits
Study medication manufacture and packing in GMP clean air-room

CONSULTING SERVICES

Publications
Expert Reports
Expert reports according to § 24 (1) German AMG (Medicines Act)
Assessment of dossiers and licencing quotations
Documentations for marketing and registration
Literature internet-enquiries
Registration support

ASSOCIATIONS

Biokinet offers co-operations with well-known research institutes. Different projects were developed, like e.g.:

The Influence of Pharmaceutical Packagings on the Discharge of Active Ingredients

During this project the primary packagings currently used (glass vials and plastic containers like PP– and PE–composites) for protein solutions and lyophilised pharmaceuticals should be analysed for interactions, especially for the adsorption ability. Stability studies under normal and accelerated conditions with packagings are carried out to evaluate the potential for optimisation to extend the shelf life time of the products. The influence of sealing systems will also be evaluated because they have an essential influence on stability of the products.

The main target of the project is to compile advantages and disadvantages of packagings currently used. Understanding this enables us to take suitable measures to optimise quality and standards. A further focus lies on the specific development or improvement of pharmaceutical packagings in direct co-operation with manufacturers of packagings.

PUBLICATIONS

LIST OF SUBSTANCES
Analytical methods are available for following substances