XPD CONSULTING

Services

We offer experience-based consulting services in the following areas

Drug discovery and development

Drug  structure evaluation
Prediction of pharmacokinetics/toxicokinetics (ADMET)
Identification of structural alerts for toxicity (reactive metabolites) and DDIs
Prediction of clearance pathways (metabolism and transport) 
Prediction of victim & perpetrator potential (substrate, inhibition and induction)
Drug candidate ranking and prioritization of safety studies
MIST (Metabolites in Safety Testing) and metabolite-drug interactions

In vitro ADMET and non-clinical safety studies


Design and prioritization of studies (metabolism, inhibition, induction, PK/TK, bioanalysis, etc.)

Laboratory qualification (GLP) and QA audits

Study placement and project management

Report, project and compliance review

Data analysis and in vitro-in vivo extrapolation (IVIVE)

Interpretation of unusual or unexpected findings

Design of mechanistic studies


Clinical studies, regulatory agencies and technical writing


Consultation on the design and interpretation of clinical metabolism, DDI, special populations, and mass balance studies
Review and/or preparation of:
Clinical Investigator’s Brochure
Regulatory submissions (IND and NDA)
Responses to questions from regulatory agencies/rapporteurs
Position papers (expert opinions) and literature reviews
Manuscripts
Consulting at FDA advisory meetings



Continuing Education


See Courses/Lectures