Pre-clinical pharmacology
We believe pharmacology is the core of drug development. When investigating a drugs action it is of highest importance to keep the translational line-of-sight through early in vitro and in vivo to clinical studies and human disease. We have extensive experience of working with in vitro and in vivo pharmacology. Together with our large network of other key expertise within drug discovery and development we help you to plan and design the most optimal studies.
In combination with Truly Labs we offer consultancy and specialized experimental services.
Planning
- Identification and design of key experiments – We review your project needs to identify and design the most optimal experiments. We work with our project Platform of Evidence (PoE) tool, to obtain a clear overview of available data and identify the gaps.
In vitro pharmacology
- Mode-of-Action (MoA) – In vitro cell studies to understand the compound Mode-of-Action. This can include antagonist/agonist characterization, signalling pathway analysis, binding characteristics, internalization of antibodies and much more.
- Functional assays – Adequate assays to investigate potency and efficacy of your compound, with focus on human disease-relevant systems.
In vivo pharmacology
- Customized pharmacodynamics (PD) models – A good PD model can provide pivotal information for understanding the efficacy, dose-response and time-effects of a drug. PD makers can often continue to serve as early target engagement biomarkers in man.
- Pharmacokinetic (PK) studies – We generate pharmacokinetic profiles in an individual animal, creating high robustness in your data. We can assist you with bioanalysis and ensure the best PK parameter determination using the industry-standard software Phoenix® WinNonlin®. Read more HERE
- Modeling of PK/PD relationships and dose predictions – A better understanding of the PK/PD relationship of your compound will provide key information for successful pre-clinical development and clinical design e.g. dose to man prediction et c.
- Administration routes and proper formulation – Delivery route and drug formulation is of key importance for success. We perform in vivo studies using most administration routes in rodents, including inhalation (Click HERE). Through close collaboration with formulation experts we can ensure optimal formulation of your drug.
Data evaluation
- Data evaluation – Data is your strongest asset. Make the most out of it. We evaluate complex data sets, integrating and summarizing to support rational decision-making.
Outsourcing
- Identify and coordinate CRO’s & KOL’s – To get most value out of your time and money it is essential to choose CROs or KOLs that have the right knowledge and the capabilities you need.
We can also offer
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In vivo
Truly Labs provides a number of different animal models and technologies.
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In vivo – Imaging
Truly Labs preforms imaging studies using different modalities incl. optical imaging, CT, MRI and PET.
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In vitro
Truly Labs offers a wide range of in vitro services including Cell-based Assays such as Mode-of-Action and efficacy assays, and Biomarker Analysis.
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Inhalation
Inhalation is of relevance for all therapeutic indications where systemic exposure is desired.