For those interested. ADC guidance for industry was issue by FDA on March 1st. This guidance includes recommendation for bioanalysis in addition to PK. In case you haven't seen this.
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry | FDA
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Jim Shen PhD
Executive Director, Head of Regulated Bioanalysis Operations
Bristol-Myers Squibb
Princeton NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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