Antisense oligonucleotides are reshaping drug design, from RNase H gapmers to inhaled delivery; this FAQ explains how they work and why trials still fail.
News|Events|July 31, 2026
FAQ: What You Need to Know About Analytical Method Validation (LOB, LOD, LOQ, Acceptance Criteria, and Equivalence Testing)
Author(s)Feliza Mirasol
We answer readers’ top questions on limit of blank, limit of detection, limit of quantitation, acceptance criteria, and equivalence testing in analytical method validation.
Advertisement
Advertisement
Validation demonstrates that an
Related to this article
Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
BMS's Dr Nathan Pennell outlines how biomarker testing barriers and trial diversity affect patient access to targeted oncology drugs.
The FDA approved Roche's satralizumab (Enspryng), an IL-6 receptor-targeting monoclonal antibody, for adults with thyroid eye disease based on the Phase 3 SatraGO-1 and SatraGO-2 trials, giving patients the first at-home subcutaneous treatment option.
Odyssey's 146-patient phase 2a trial will pair OD-001 with vedolizumab, targeting both innate and adaptive immune drivers of ulcerative colitis.
MT027, T-MAXIMUM's B7-H3 CAR-T therapy, earns a second FDA-cleared phase 2 trial, now testing lung and breast cancer brain metastases.
In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.
Guselkumab (Tremfya) sustained perianal fistula healing through 1 year in Crohn disease, with remission climbing to 35% in one FUZION dosing arm.
Advertisement
Advertisement