Benefit from our ultra sensitive PK/PD bioanalytical sample testing
Pharmacokinetics (PK) describe all processes that an administered drug is subject to in the body as a function of time, including absorption, biodistribution, metabolism and excretion.
Pharmacodynamics (PD) describe how the body responds to the drug in terms of biochemical interactions, like receptor binding or post-receptor effects. The resulting data give concentration time profiles of the drug and its metabolites, providing an understanding of what the body does to the drug.
This dose-response relationship is highly helpful to estimate the drug’s efficacy, duration, and safety, and thus to identify dosage and distribution for preclinical and clinical studies.
Our immunoassay validation is carried out as detailed by the guidelines for Bioanalytical Method Validation
• Federal Drug Association (FDA)
• European Medicines Agency (EMA)
We provide ultra sensitive bioanalytical support for modern biotherapeutics throughout all phases of drug development. Our immunoassay validation is compliant to GLP/GCP regulations and follows international industry guidance (FDA, EMA, ICH) to ensure that your bioanalytical method is well characterized, fully validated, and documented.
We also gladly assist you to select the most appropriate technology platforms for your research project and develop, optimize, and transfer PK assays to Imperacer®, Simoa®, MSD™ or ELISA.
From TOX to clinic
We have a long track record of supporting trials targeting a wide range of disease areas including oncology and neurology (CNS), as well as inflammatory, infectious, metabolic and rare diseases, in all phases of drug development
We also have long-running experience in diverse and rare matrices, like serum/plasma, CSF, cell culture/medium, tissue extracts, mouse tail vein, tears, saliva, synovial fluid and many more. Virtually any matrix can be explored utilizing the Imperacer® platform's outstanding ability to maintain extreme sensitivity despite high sample dilution.
Combining broad quantitative range with excellent sensitivities, we are able to support biologics PK using a single assay format. From high dosing in TOX through extreme low dosing in dose-escalation to the later clinical stage, we provide regulated PK sample testing using validated methods, based on the same assay. This eliminates the need to run several assays to pair sensitivity and range.
As we have the capability to measure low concentrations of a given drug, we are able to provide a complete PK profile even for initial doses and thus shorten Phase I trials. Our high-quality data meet your regulatory requirements and can be decisive to evaluate ongoing dose escalation.
Literature list PK
|Selection of Critical Reagents for Development of an Ultra Sensitive Immuno-PCR Based Method for Detection of Botulinum Toxin-A in Several Matrices||request reprint|
|Randomized Phase I Trial of the Safety/Tolerability of Anti-Lingo-1 mAB BIIB033|
|Phase-I “Proof of Principle”: Immunization with Virosome-Gp41-Derived Antigen Induces Mucosal Antibodies with Antiviral Properties to Reduce Risk of HIV-1 Infection||request reprint|
|Development of an Imperacer Method for Clinical Phase 1a Human Trial of ShK-186, a Specific and Potent Peptide Inhibitor of the Kv1.3 Potassium Channel|
|Development of an Immuno-PCR Method with Extreme Robustness against the Presence of Endogenous Counterpart for Clinical PK Study Bioanalytical Support of Replacement Therapy Fc-fusion Protein||request reprint|
|Development and GLP-Validation of Imperacer® (Immuno-PCR) Methods for Ultra Sensitive Quantification of Mucosal Antibodies in Support of Phase-I Clinical Trial for a Novel Vaccination Strategy in Preventing HIV Infection||request reprint|
|Comparison of Two Immunoassay Technology Platforms for Bioanalytical Sample Testing Support in PK Profiling of a Non-disclosed Lead Candidate in Diabetes: ELISA vs. Imperacer||request reprint|
|Pharmacokinetics of Natural Mistletoe Lectins after Subcutaneous Injection|
|Adaptation and Performance of an Immuno-PCR Assay for the Quantification of Aviscumine in Patient Plasma Samples|
Literature list PD
|Clinical Biomarker Quantification: Novel Tools for Pharmacodynamic Applications|
|Challenges in Developing a Sensitive PD Assay–From Tool Selection to Technologies Evaluation||request reprint|