INTRODUCTION

The potency of several Pharmacopeial articles must be determined by bioassays. The aim of this chapter is to present a concise account of certain essential biometrical procedures for bioassays in chapters or monographs of USP–NF, namely outlier identification, confidence intervals for relative potency measurements, and combination of independent assays. For bioassays not in USP–NF, other methods may be appropriate. See general information chapter Analysis of Biological Assays 〈1034〉 which may be a helpful, but not mandatory, guidance.