Protein binding determination, QC and acceptance criteria: an interview with Simon Wong
In this interview Simon Wong (Director of DMPK at Pliant Therapeutics, CA, USA) discusses his relationship with QPS, through supporting the definitive plasma protein binding for candidates. He explains regulatory guidance and how important it is to understand the unbound concentration of a new chemical entity because of the unbound drug hypothesis. Simon explains the gold standard for the determination of protein plasma binding, what to consider when using QCs and how to set acceptance criteria for plasma protein binding.
Questions include:
- What type of protein binding determination system do you use?
- What kind of QCs and how many QCs should be included?
- What defines the acceptance criteria and how do you set acceptance criteria?
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