The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Analytical performance should lead method decisions, but optimization can still reduce solvent, energy, and waste provided ...

The digital transformation of pathology is opening up new possibilities for cancer diagnosis. Today's artificial intelligence ...

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for ...

An overview of the validation and qualification requirements introduced in the 2022 EU GMP Annex 1 revision, with a focus on ...

Researchers from University Hospital Cologne have developed an autonomous agent-based AI system called ‘SPARK’ that acts as a “digital brain” / publication in ‘Nature Medicine’ The digital ...

Dr. Dominic Gostick, CTO at PerkinElmer, discusses the transition in the lab toward integrated systems, how AI-enabled ...

Potency assay development uses DoE and QbD to improve accuracy, consistency, and regulatory readiness in biologics testing.

In 2026, the intelligence community (IC) is facing an unprecedented challenge, and tactical-level intelligence ...

Global Immune Repertoire Sequencing Market OverviewThe global immune repertoire sequencing market is projected to expand at a steady compound annual growth rate of approximately 10% during the ...

From data quality and AI readiness to the realities of clinical translation, industry leaders share where precision still ...

Jonathan D. Uslaner and Matthew Goldstein of Bernstein Litowitz Berger & Grossmann LLP examine the proposed new Federal Rule ...