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
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For more information, contact: Bob Guttendorf (rguttendorf@aclairo.com)
