Preclinical ADME and Clinical Pharmacology

Preclinical ADME

Aclairo offers complete preclinical ADME (absorption, distribution, metabolism, excretion), pharmacology, and pharmacokinetic (PK) strategy and implementation services to help your molecule get into the clinic and through development as efficiently as possible. In addition, Aclairo provides regulatory guidance to ensure positive interactions with regulators. Aclairo is staffed with scientists and consultants with expertise in preclinical ADME/PK, who can support your drug development projects in a wide range of areas.

  • Preclinical ADME/PK plan development and implementation
    • Strategy for development of biologics, small and large molecules
    • Strategy, study planning and evaluation, and regulatory submissions
    • Study monitoring, planning and support
    • Data analysis, interpretation, and presentation
  • Regulatory ADME, pharmacology, and toxicokinetics (TK)
  • Critical review and gap analysis of submissions
  • Due diligence
  • Preclinical ADME gap analysis for development programs at IND, EOP2, NDA and CTD stage

Aclairo consultants have expertise in:

  • Bioanalytical assay implementation and interpretation
  • Toxicokinetics
  • PK and PK/PD (pharmacodynamic) modeling
  • In vitro and in vivo ADME, including transporters
  • Drug-drug interactions (DDI)
  • Discovery ADME screening
  • Preclinical-to-clinical translation

Clinical Pharmacology

Aclairo offers complete clinical pharmacology, pharmacokinetic (PK), and ADME strategy and implementation services to help your molecule get into the clinic and through development as efficiently as possible. Aclairo also provides regulatory guidance to ensure positive interactions with regulators.

Aclairo is staffed with scientists and consultants with expertise in preclinical and clinical ADME/PK, who can support your drug development projects in a wide range of areas.

  • Clinical Pharmacology plan development and implementation
    • Strategy for development of biologics, small and large molecules
    • Strategy, study planning and evaluation, and regulatory submissions
    • Study monitoring, planning and support
    • Data analysis, interpretation, and presentation
  • Regulatory Clinical Pharmacology and ADME
  • Critical review and gap analysis of submissions
  • Due diligence
  • Clinical Pharmacology gap analysis for development programs at EOP2, NDA and CTD stage

Aclairo consultants have expertise in:

  • Bioanalytical assay implementation and interpretation
  • PK and PK/PD (pharmacodynamic) modeling
    GLP Study Reports Now Available!
  • In vitro ADME, transporters, drug-drug interactions (DDI) to inform Clinical Pharmacology strategies
  • Preclinical-to-clinical translation
  • Clinical pharmacology programs
    • First-in-human studies (dose selection, design, analysis, reporting)
    • Food effect
    • Bioavailability/bioequivalence
    • Formulation assessment
    • DDI studies
    • Special population studies

For more information, please contact: Bob Guttendorf