Abstract
Commercial clinical drug development requires formulating the clinical development plan, executing the plan, compiling the regulatory dossier, and regulatory review and approval of the dossier. Streamlining the development plan with fewer but larger studies, executing the plan using a trial management organization (TMO) approach, taking a proactive, standardized approach to compiling the regulatory dossier, and requiring total quality may shorten the total time required to approval.
| Original language | American English |
|---|---|
| Pages (from-to) | 257-264 |
| Number of pages | 8 |
| Journal | Therapeutic Innovation and Regulatory Science |
| Volume | 24 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 1 1990 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Scopus Subject Areas
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Public Health, Environmental and Occupational Health
- Pharmacology (medical)
Disciplines
- Public Health
- Biostatistics
Keywords
- Clinical
- Proactive
- Quality
- Standardization
- TMO
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