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As more and more innovative drug products (e.g., chemical drug and biological drug products) are going off patent protection, the development of generics/biosimilars products have become the center of attention of many pharmaceutical companies. In addition, as new drug research and development has reached the bottle-neck, the pharmaceutical industry begin to focus on the search for new or alternative medicines such as traditional Chinese medicine that can treat critical and/or life-threatening diseases. To ensure that there is high probability of success, advanced technology and/or methodology and innovative thinking of trial designs are necessarily applied. The advanced technology/methodology include two-way translational process from bench-to-bedside in translational research, micro-dosing approach for safety evaluation, and big-data analytics for identifying hidden clinical benefits of some test treatments. The innovative thinking of trial designs are referred to adaptive trial designs for identifying optimal clinical benefits of the test treatment under investigation and/or biomarker induced targeted clinical trials for personalized (precision) medicine. Along this line, this short commentary provides perspectives of future pharmaceutical development of biosimilar products and traditional Chinese medicine.
Adaptive trial design, Micro-dosing approach, Big-data analytics, Precision medicine, Biosimilars, Traditional Chinese medicine