This chapter also will discuss the more recently approved and implemented ICH E14/S7B Q&A guidance, which outlines the acceptance of in vitro hERG (human ether-a-go-go related gene) and in vivo QT interval study data (i.e., nonclinical, double ...
“Initial Process Studies”, toprovide for the use of either Cpk or Ppk, depending on the amount and type of data available, consistentwith our Statistical Process Control reference manual;•Clarification of when customer notification and/or submission is required;•The prior IASG QS-9000 ...