Related Experiment Video
Updated: Jun 6, 2026

Assay Development for High-Throughput Drug Screening Against Mycobacteria
Published on: October 25, 2024
Development and regulatory strategies for drug and diagnostic co-development
Lois M Hinman1, Kevin M Carl, Brian B Spear
1Novartis Pharmaceuticals Corp., East Hanover, NJ 07939-1080, USA. lois.hinman@novartis.com
Abstract:
At the 5th FDA-Drug Industry Association (DIA) Workshop on 'Pharmacogenomics in Drug Development and Regulatory Decision Making', track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit-risk paradigm for new drugs.
Related Concept Videos
Preclinical Development: Overview
Clinical Trials: Overview
Drug Discovery: Overview
Drug Regulation
Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Clinically Relevant Drug Product Specifications: Methods of Establishment
