“The adoption of biomarkers holds promise in facilitating the availability of safer and more efficacious drug and biotechnology products, guiding dose selection, and refining their benefit-risk profile,” as outlined by the FDA ICH E16 guidelines.
The evolution from a “one drug fits all” approach in drug discovery to personalized medicine marks a significant triumph in modern pharmaceuticals. Biomarkers serve as pivotal agents in driving this shift.
The objective of integrating biomarkers into research endeavors is to streamline the drug development process, expediting the production of drug therapies while upholding safety standards. Biomarkers enhance animal testing efficacy and refine human risk assessment practices. At Chromed Biosciences, we provide a comprehensive array of safety, efficacy, and surrogate biomarker services tailored to meet the evolving needs of drug discovery and development.