Take Care of the Fast‐in‐Human Study
Clearly, the ever‐present time pressure requires the successful drug developer to balance good science with good business, without compromising safety or ethical standards The no‐time‐to‐lose pressure can impose a “bar chart‐driven” approach to clinical development, as if it were a manufacturing pro...
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| Veröffentlicht in: | Clinical and translational science 2017-05, Vol.10 (3), p.122-123 |
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| container_title | Clinical and translational science |
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| creator | Hoogdalem, E‐J |
| description | Clearly, the ever‐present time pressure requires the successful drug developer to balance good science with good business, without compromising safety or ethical standards The no‐time‐to‐lose pressure can impose a “bar chart‐driven” approach to clinical development, as if it were a manufacturing process, with critical path analysis, processes run in parallel, and independent critical milestones, triggering the next development step. New data requiring reassessment of the development plan are the reason we do studies: we learn about the product, and if needed we adjust and improve the plan with the ultimate goal of patient safety and the optimal package insert and label claims in mind. [...]three key principles in the design of the first clinical evaluation of an experimental product in humans are recommended: |
| doi_str_mv | 10.1111/cts.12437 |
| format | Article |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Wiley Online Library Open Access; EZB-FREE-00999 freely available EZB journals; Wiley Online Library All Journals; PubMed Central |
| subjects | Amidohydrolases - antagonists & inhibitors Amidohydrolases - metabolism Animals Brain Diseases - chemically induced Brain Diseases - diagnosis Commerce Critical path Critical path method Cyclic N-Oxides - adverse effects Cyclic N-Oxides - economics Disclosure Drug Costs Drug Development - economics Drug Development - ethics Drug Development - methods Drug Industry - economics Drug Industry - ethics Enzyme Inhibitors - adverse effects Enzyme Inhibitors - economics Ethical standards Ethics Humans Patient Safety Pressure Public domain Pyridines - adverse effects Pyridines - economics Regulation Risk Assessment Science Species Specificity Success |
| title | Take Care of the Fast‐in‐Human Study |
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