Application and Impact of Human Dose Projection from Discovery to Early Drug Development
| Autor: | Maya P. Lipert, Dipal Patel, Wenzhan Yang, Tian Wu |
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| Rok vydání: | 2019 |
| Předmět: |
Drug Industry
Computer science Chemistry Pharmaceutical Pharmacology toxicology Pharmaceutical Science 02 engineering and technology Aquatic Science 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Drug Development Drug Discovery Animals Humans Pharmacokinetics Projection (set theory) Ecology Evolution Behavior and Systematics Pharmaceutical industry Ecology Dose-Response Relationship Drug business.industry General Medicine 021001 nanoscience & nanotechnology Decision points Drug development Risk analysis (engineering) Pharmaceutical Preparations Drug Design 0210 nano-technology business Agronomy and Crop Science Forecasting |
| Zdroj: | AAPS PharmSciTech. 21(2) |
| ISSN: | 1530-9932 |
| Popis: | The application and impact of human dose projection (HDP) has been well recognized in the late drug development phase, with increasing appreciation earlier during discovery and early development. This commentary describes the perspective of pharmaceutical scientists on the evolving application and impact of HDP at various phases from discovery to early development, including lead generation, lead optimization, lead up to candidate nomination, and early drug development. The underlying fundamental concepts and key input parameters for HDP are briefly discussed. A broad overview of phase-specific tools and approaches commonly utilized for human dose projection in the pharmaceutical industry is provided. A discussion of phase-appropriate implementation strategies, associated limitations/assumptions and continuous refinement for HDP from discovery to early development is presented. The authors describe the phase-specific applications of human dose projection to facilitate key assessments and relative impact on decision points. |
| Databáze: | OpenAIRE |
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