Development of companion diagnostics (CDx) as powerful tools in precision medicine typically follows one of three pathways: co-development, bridging, and follow-on. Co-development is the most ideal …

The Current Status for HER2 Testing There is a large portfolio of available human epidermal growth factor receptor 2 (HER2)-targeted therapies that have an associated companion diagnostic (CDx) in …

Companion diagnostics are a class of diagnostic devices that has become important not only in personalizing therapy for patients, but also for developers of therapeutic products, who must now …

2024年9月9日 · In an era where artificial intelligence (AI) is revolutionizing healthcare and clinical research, regulatory bodies are racing to keep pace.

2022年7月1日 · As these national guidelines and regulations continue to create favorable conditions for development of drug-CDx reagents in China, industry has responded with calls for China’s …

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ulti-Regional Clinical Trials (MRCT) is not a new term and has been in use for many decades. It refers to a clinical trial conducted in more than one region under a single protocol and allows data from one …

In the rapidly evolving global pharmaceutical research and development landscape, China is transitioning from harmonization with international standards to becoming a vital innovation engine.