IBD Drug ADME/DMPK Services

As the cost of IBD drug development continues to rise, ADME/DMPK testing is critical to the selection, progress, and development of new drug candidates. Conducting ADME/DMPK studies in the early stages of drug discovery can help minimize the likelihood of compound failure, determine the potency of targets with acceptable safety profiles, optimize PK parameters, and reduce drug-drug interactions (DDIs). In later stages, ADME studies further validate toxicological assessments and support safety evaluations prior to first-in-human (FIH) studies.

Our ADME/DMPK Services

At Ace Therapeutics, we offer comprehensive and flexible in vitro and in vivo DMPK/ADME studies for IBD drugs, covering from hit-to-lead and lead optimization phase through candidate selection. We also offer metabolite profiling, structure elucidation and DDI studies for IND submission for preclinical IBD drug development.

Our ADME scientists have extensive expertise in high-throughput discovery bioanalytical and LC-MS bioanalytical platforms that support all aspects of ADME testing and PK testing. Such studies can be offered as stand-alone projects or as part of a comprehensive IBD drug discovery program. Through cost-effective, high-throughput technologies and streamlined processes, we ensure the delivery of high-quality data and fast turnaround times, aiming to reduce the time from request to results.

Our comprehensive ADME/DMPK capabilities are built on personalized study design, fast turnaround and unparalleled expertise. We provide pharmaceutical and biotech companies focused on IBD research with meticulous, decisive analytical services.

In Vitro ADME Services in IBD Drug Discovery

We perform in vitro ADME testing under strictly controlled conditions to help clients gain insight into the DMPK properties of IBD drugs.

• Physicochemical screening: Aqueous solubility (thermodynamic and Kinetic method), Log P (octanol/water), Log D (octanol/PBS).
• Permeability assays: PAMPA, CaCo-2, MDCK (wild type).
• In vitro binding assays: Plasma protein binding (PPB), blood plasma partitioning (BPP).
• Metabolic stability: Plasma stability, blood stability, metabolic stability in liver microsomes, metabolic stability in hepatocytes, intestinal metabolic stability.
• Drug-drug interactions: Cytochrome P450 (CYP) inhibition assay (based on fluorescence and LC-MS/MS).
• Metabolite identification/profiling: Analysis of fecal or urine samples and intestinal tissue can be performed to quantify compound and metabolite levels.

In Vivo ADME Testing in IBD Drug Development

• Radiolabeled compound synthesis
• Radiolabeled PK
• Excretion balance in rodents and non-rodents
• Tissue distribution/Quantitative Whole-body Autoradiography (QWBA)
• In vivo plasma protein binding studies

Pharmacokinetic Evaluation of IBD Drugs

Using state-of-the-art analytics (HPLC-MS) and specialized models, we help clients characterize the pharmacokinetic profile of IBD drugs and inform the efficacy of an IBD drug by validating that it reaches the required concentration levels in plasma and tissues.

• Rank-ordering compounds
• Formulation screening
• Standard and special PK
• Excretion balance
• Tissue distribution (non-radioactive and radioactive)
• Metabolite quantification
• Drug-drug interactions
• Pharmacodynamic and pharmacokinetic/pharmacodynamics modeling

Bioanalytical Services in IBD Drug Development

Ace Therapeutics' full range of bioanalytical services support the development of small and large molecule drugs for IBD.

• Discovery (non-GLP) bioanlaysis
• Metabolite profiling and identification
• Dose-formulation analysis
• Regulated bioanalytical method development and validation
• Method development and transfer
• Cross-validation of bioanalytical methods
• Analysis of biomarkers

Metabolite Profiling and Identification in IBD Drug Discovery

Ace Therapeutics provides comprehensive metabolite profiling and identification services to profile, isolate, analyze and identify metabolites in support of IBD drug discovery and safety studies.

Our capabilities include:

• Radio-synthesis of ³H or ¹⁴C-labelled compounds
• Isolation and purification of metabolites
• Metabolite structure elucidation
• Metabolic soft-spot determination
• Cross-species metabolite characterization using liver microsomes and hepatocytes with unlabeled and radiolabeled test compounds
• Mechanistic studies (Reactive metabolites, mechanism of chiral inversion, etc.)
• In vivo metabolite profiling and identification in rodent and large animal species
• Safety testing of metabolites

Ace Therapeutics' has ADME/DMPK services range from expert in vitro ADME and in vivo PK to full-scale digital lab operation and management. We prioritize working closely with our clients to fully understand their time and cost requirements and expectations, ensuring a transparent and tailored approach to each project. If you are interested in our services, please do not hesitate to contact us.