Bioanalytical Services for Small Molecule Drug Development
Bioanalytical Services for Small Molecule Drug Development
Bioanalysis of small molecule drugs is crucial for understanding their pharmacodynamics (PD) and pharmacokinetics (PK), providing detailed insights into how these drugs affect gene and protein expression, which is essential for determining their efficacy, safety, and mechanism of action. Accurate bioanalysis supports the optimization of drug dosing, identification of biomarkers for therapeutic response, and compliance with regulatory standards, ultimately facilitating the development of effective and safe small molecule therapeutics
Our Expertise
While we do not typically analyze small molecules directly, we leverage advanced genomic and proteomic tools to study gene expression and protein expression. Our expertise in technologies such as qPCR, ddPCR, ELISA, MSD, and LC-MS/MS allows us to provide precise and insightful analysis of molecular responses to small molecule drugs. By focusing on gene and protein expression, we offer crucial insights into the pharmacodynamics (PD) of your drug candidates, supporting the successful advancement of your development programs.
Analytical Support Through All Stages of Product Lifecycle
Phase
Technologies
Application
Preclinical
- In vitro efficacy studies
- Gene Expression Analysis
- Protein Expression Analysis
Regulatory Guidance
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.” FDA is publishing this draft guidance which, when finalized, will provide recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled “Control of Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine...
This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or payload. Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology considerations and recommendations for bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors,...
