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In Vitro ADME/Tox
In Vivo PK
Bioanalysis
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In Vitro ADME Study Design & Data Interpretation
In Vivo PK Study Design & Data Interpretation
Bioanalysis Study Design & Data Interpretation
Formulation Design
Dosing Regimen Design & PK Modeling
Interspecies PK Scaling & Human PK Prediction
Structure-Property Relationships & Drug Design
ADME/PK Screen & Lead Selection/Optimization Strategies
Write or Review ADME/PK Sections of Regulatory Files (IND, IMPD, IB, CTA, etc.)
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Tiered Approach to Scientific Validation - 2015
FDA Guidance Documents (file downloads)
Recent Issues in Bioanalysis-Small Molecules-2014
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White Papers (file downloads)
Recent Issues in Bioanalysis-Large Molecules-2014
FDA-Guidance for Industry-Bioanalytical Method Validation-Sep2013
GOING ABOVE AND BEYOND
EMA Guidance Documents (file downloads)
EMA-Guideline on the Investigation of Drug Interactions-21Jun2012
FDA-Guidance for Industry-Drug Interaction Studies-Oct2017
EMA-Guideline on Bioanalytical Method Validation-21Jul2011
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