One size does not fit all

“Validation guidelines to support biotherapeutic research and development can no longer be an after-thought, tacked on to a guideline focused mainly on a small-molecule framework.” The time is right to stop trying to fit a square peg into a round hole. The Regulators’ Guidance on Acceptable Validation of Bioanalytical Methods to Support Pharmacokinetics (PK) was received with relief all those years ago, when drugs were almost solely derived from small molecules. As the world evolves so does science and today most of the new medical entities are biologically based. The guidance that served many so well two decades ago lacks...