In addition to in-house testing, Absorption Systems coordinates outsourced toxicology and pharmacokinetic studies and other tests to optimal facilities by leveraging a global network of CROs (Contract Research Organizations). Here, we introduce Absorption Systems' features and disease models.
By leveraging a network of numerous partner CROs, we offer access to a wide range of non-clinical studies, including toxicology, DMPK/ADME, safety pharmacology, disease models, and even the biodefense sector. Because our services are not limited to specific areas, we can provide consistent support from early drug discovery through late-stage development.Rapidly secure optimal testing resources according to the client's research content and development phase.The ability to do so is a major strength.
Depending on the client's testing objectives and target market,Accurately match CROs with facilities and systems that comply with the standards of various regulatory authorities such as OECD GLP, FDA, and EMA.They also support the creation of regulatory dossiers, including IND applications, and propose study designs that meet requirements. They can build a consistent non-clinical strategy with the approval process in mind.
One of the features of Absorption Systems isFacility selection from a neutral position, independent of specific CROsThis allows us to select the most suitable CRO globally for each project, optimizing the balance between quality, cost, and schedule. It also enables us to reduce unnecessary costs while diversifying risks, thereby increasing the probability of project success. We achieve efficient and strategic non-clinical development.
Absorption Systems leverages a global network, not limited to specific CROs, to select the most suitable contract research organization for each project.
As an example, I can introduce a contract company like the following.
Absorption Systems collaborates with specialized CROs such as Biocytogen to provide access to humanized mouse models that replicate the human immune system. These models are useful for evaluating immune responses and the efficacy and safety of antibody drugs.
We can provide a variety of cancer models suitable for tumor development, progression, and efficacy evaluation. By utilizing transplantable and genetically modified models, we can accurately assess the effects of anti-cancer drugs and immunotherapies.
There were no specific written examples of non-clinical studies.Solving the challenges of "lack of specialized resources" and "complex regulatory compliance" faced by pharmaceutical and biotechnology companies in non-clinical developmentWe will engage in strategic study design for New Drug Application (IND) filings, select optimal partners from a global pool of CROs (Contract Research Organizations), and delegate the overall monitoring of studies. We provide extensive expertise in toxicology, pharmacokinetics, and safety pharmacology to enhance the reliability of study data and ensure compliance with regulatory requirements. We offer comprehensive support to minimize the risks of development delays and technical issues, efficiently advancing projects within limited budgets and timeframes.
| Address | 436 Creamery Way, Suite 600, Exton, Pennsylvania 19341, USA |
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| Tel | +1-610-280-2000 |
| Website | https://abogenbio.com/ |
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.