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Model Firsts

By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions.

Author(s): Karen Tkach Tuzman
Solution: Systems Pharmacology
Publication: BioCentury Innovations
Therapeutic Area: Central Nervous System
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Value-focused Drug Development Strategies of the Future

Mounting healthcare and R&D costs, high drug attrition rates leading to decreased numbers of new molecular entity approvals, and growing demands from regulators and payers indicate that a paradigm shift is needed to improve efficiency and productivity across the drug development continuum.

Author(s): Craig Rayner
Solution: Clinical Pharmacology Strategy, Drug Development & Regulatory Strategy
Publication: Australasian BioTechnology
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Clinical Pharmacology—The Quarterback of Drug Development

Clinical pharmacology accounts for about 50% of a drug label. Its scope ranges from facilitating the discovery of new target molecules to determining the effects of drugs in different populations. From both industry-wide and regulatory perspectives, the levers of clinical pharmacology can address the huge challenges of late-stage attrition and increase the efficiency of drug development in the quest to bring the “ball” into the end zone.

Author(s): Ellen Leinfuss, Julie Bullock
Solution: Clinical Pharmacology Strategy
Publication: Clinical Researcher
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Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future

The identification of different responsibilities, under the clear leadership of the medical writer, is necessary to improve the quality of clinical study protocols – to prevent problems and mistakes that can result later, during conduct of the clinical trial, or afterwards, when reporting on trial results.

Author(s): Kelley Kendle
Solution: Drug Development & Regulatory Strategy, Regulatory & Medical Writing
Publication: Medical Writing
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