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The shift toward precision medicine has altered the landscape of drug development, moving the industry toward therapies tailored to specific biological profiles. The success of these programs depends on the ability to identify, validate, and quantify biological…

The implementation of a cohesive biomarker strategy is one of the most critical elements of getting a drug candidate from early discovery through clinical development. A common pitfall, however, is the assumption that the analytical methods used in early research will…

The transition from a lab concept to a viable clinical drug candidate often relies on accurate measures of biological activity. Biomarker assays serve as these essential yardsticks, providing the data necessary to verify target engagement, assess safety, and predict…

The progression of a therapeutic candidate from preclinical development to clinic readiness depends heavily on the ability to quantify biological responses accurately. While discovery-phase research focuses on identifying potential indicators of efficacy, the…

Antibody-drug conjugates (ADCs) are one of oncology’s most productive modalities because they promise something every drug developer wants: potent tumor destruction with greater selectivity than conventional cytotoxic therapy. As our understanding of ADCs matures, one…

Bioanalytical method development and validation serve distinct yet highly important purposes. Development is the process of establishing an assay’s chemistry and parameters, whereas validation is the formal demonstration that the assay is fit for its intended use….

Bioanalytical method validation is the process of confirming that an analytical method is accurate, precise, and reliable for its intended use in drug development. It ensures that pharmacokinetic, immunogenicity, and biomarker data meet regulatory expectations for IND…

The transition from discovery to clinical application is among the most volatile (yet important) phases in drug development. The ability to navigate this transition depends on the integrity of the data generated during early-stage evaluations, the period in which…

Bioanalytical services play a critical role in determining whether an Investigational New Drug (IND) application proceeds on schedule or encounters delays. The technical execution of a bioanalytical strategy is a critical contributor to the speed of regulatory…

Transdermal drug delivery is one of the oldest methods of administering medications to humans. These methods can be traced back to the Ancient Egyptians, who used oils, fats, perfumes, and other ingredients to make cosmetic and dermatological products. Yet…

How to deal with toxicology when developing novel therapeutic modalities.

How skin irritation and corrosion testing based on reconstructed human epidermis models has evolved.