SOLO – DMPK – Bioanalysis

SOLO DMPK & Bioanalysis: Studying the metabolism and pharmacokinetics of your new therapeutic entities

SOLO DMPK & Bioanalysis is a complete panel for the evaluation and characterization of ADME-T (Absorption, Distribution, Metabolism, Excretion and Toxicity), pharmacokinetic, regulatory and non-regulatory bioanalytical support of your chemical or biological molecules. It is an integral part of the discovery and development pathway of new therapeutic entities from the early Hit Finding phase, the selection of preclinical drug candidates and up to the submission of the IND /CTA dossier before clinical entry.

Accelerate the optimization of molecules and the selection of drug candidates

From Target to IND
  • Target to hit

    Evaluation of physicochemical and in vitro ADME properties

    • Solubility
    • LogD
    • Microsomal strability
    • CYP inhibition
  • Hit to Lead

    Optimization of physicochemical and drug-like properties

    • Metabolic stability
    • CYP inhibition
    • Permeability
    • In vitro plasma protein binding
    • Combined PK-BBB
    • Unbound Partition Coefficient (Kpu,u brain)
  • Lead to candidate identification

    Optimization of drug-like properties, IVIVC, PK/PD correlation

    • Permeability
    • In vitro plasma protein binding
    • PK studies (rodents & non-rodents)
    • Target tissue exposure
    • Blood/plasma partitioning
    • Mass balance
    • PK/PD studies
    • Metabolites identification
  • Candidate selection

    Dose range finding, safety/tox evaluation, human dose prediction

    • Dose range finding (rodents & non-rodents)
    • Tissue distribution
    • Food effect
    • Metabolite profiling
    • Interspecies scoring
    • Metabolites identification
    • CYP induction

Based on our experience in a large number of drug candidate discovery projects, SOLO DMPK & Bioanalysis is an expert solution to guide the characterization of the developability of new therapeutic molecules:

  • Through ad hoc in vitro ADME-T prediction studies
  • Via pharmacokinetic (PK) profile and PK/PD relationship assessment studies in rodents (including pathological models) and other animal species
  • Or in the design of an integrated set of in vitro and in vivo assays and decision trees tailored to the different stages of progression of your discovery program, from target to hit to preclinical candidate selection, and therapeutic dose prediction in humans.
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Regulatory Bioanalysis services
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Our expertise in DMPK & Bioanalysis

We offer specialized support in regulatory bioanalysis from preclinical to clinical development of new and various chemical and biological entities. GLP analysis by mass spectrometry, quantitative PCR, flow cytometry and ligand binding assays are an integral part of our established expertise and know-how.

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