[Yes, I meant to spell it that way. It’s a new word, blame FDA.]
There’s an interesting shift in language between FDA’s Draft and Final Guidance on Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases:
Draft:
Final:
This looks to me like FDA backing away from language evocative of “balance” — perhaps to escape @Stephen Senn’s wrath — while still retaining the essential license this idea grants. If I’m not wrong, FDA wants here to treat randomized dose assignment in ‘dose optimization’ trials as guaranteeing the validity of naive comparisons that eschew statistical considerations.