Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Apr 2019
EditorialRegulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation.
Regulatory science is defined as science and research intended to inform decision making in a regulatory framework. This issue of Clinical Pharmacology & Therapeutics and the papers herein deal with the expansive topic of regulatory science and its role in fostering innovation and accelerating access to medicines. Regulatory health authorities, industry, and multiple stakeholders have a shared objective in advancing regulatory science to keep up with the ever-increasing pace of biomedical science.
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Adaptive Biomedical Innovation (ABI) is a multistakeholder approach to product and process innovation aimed at accelerating the delivery of clinical value to patients and society. ABI offers the opportunity to transcend the fragmentation and linearity of decision-making in our current model and create a common collaborative framework that optimizes the benefit and access of new medicines for patients as well as creating a more sustainable innovation ecosystem.
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Clin. Pharmacol. Ther. · Mar 2016
EditorialBig Data Transforms Discovery-Utilization Therapeutics Continuum.
Enabling omic technologies adopt a holistic view to produce unprecedented insights into the molecular underpinnings of health and disease, in part, by generating massive high-dimensional biological data. Leveraging these systems-level insights as an engine driving the healthcare evolution is maximized through integration with medical, demographic, and environmental datasets from individuals to populations. Big data analytics has accordingly emerged to add value to the technical aspects of storage, transfer, and analysis required for merging vast arrays of omic-, clinical-, and eco-datasets. In turn, this new field at the interface of biology, medicine, and information science is systematically transforming modern therapeutics across discovery, development, regulation, and utilization.
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This issue of Clinical Pharmacology & Therapeutics focuses on cannabinoids. Our understanding of these interesting endogenous and synthetic compounds, and their role in the cannabinoid system, has evolved dramatically, in part because of the acquisition of new research tools. ⋯ Novel cannabinoid drugs are emerging for medicinal use (e.g., dronabinol, nabiximols) and as illicit drugs (e.g., Spice, K2) perpetuating the perception that cannabinoid drugs can be a friend or foe. This special issue will cover these various aspects of cannabinoid pharmacology and therapeutics ranging from basic chemistry, pharmacokinetics, pharmacodynamics, and clinical trial results, to policy and education efforts in this area.