Bioanalytical testing services
STZ OcuTox is a service provider of analytical testing and validation to the pharmaceutical industry, and smaller biotechs or start-ups. We develop, customize and validate assays of drug candidates and metabolites in biological matrices such as tears, conjunctiva, bulbar conjunctiva, aqueous humor, cornea, vitreous, retina, choroid, sclera, plasma and blood in order to support preclinical and/or biopharmaceutics and clinical pharmacology programs.
BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION :
In addition to a long list of available bioanalytical methods, STZ OcuTox develops custom methods and can also improve and validate clients' existing methods. STZ OcuTox offers bioanalytical method validation to support international submissions of investigative and new drug substances and products:
Human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation.
Non-human pharmacology/toxicology studies.
STZ OcuTox can process samples using mass spectrometry, chromatography and other analytical techniques such as
Immunoanalysis with EIA-RIA-ELISA measurement or measuring radioactivity.
STZ OcuTox conducts method validations before and during the bioanalysis of test samples in accordance with recognized international recommendations and guidelines, including those issued by the:
United States Food and Drug Administration (FDA).
International Conference on Harmonisation (ICH).
Organization for Economic Cooperation and Development (OECD).