Challenges and Solutions for Clinical Development of New Antibacterial Agents: Results of a Survey among Pharmaceutical Industry Professionals
| Autor: | Esther Bettiol, Stéphan Juergen Harbarth, Jeffrey D. Wetherington, Nicolas Schmitt |
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| Rok vydání: | 2015 |
| Předmět: |
ddc:616
Pharmacology Knowledge management Drug Industry business.industry Diagnostic test Anti-Bacterial Agents Infectious Diseases Clinical Protocols Drug Resistance Multiple Bacterial Surveys and Questionnaires Drug Discovery Commentary Humans Clinical trials clinical development antibacterial agent multi-drug resistant organisms regulatory clinical trial design pathogen-based trial indication-based trial pharmaceutical companies Pharmacology (medical) Business Adaptation (computer science) Drug industry Pharmaceutical industry |
| Zdroj: | Antimicrobial Agents and Chemotherapy, Vol. 59, No 7 (2015) pp. 3695-99 |
| ISSN: | 1098-6596 0066-4804 |
| DOI: | 10.1128/aac.00638-15 |
| Popis: | As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial and regulatory. For multidrug-resistant organisms, there are needs for rapid diagnostic tests, new regulatory guidance, and adaptation of endpoints/trial designs. Regulators and public/private initiatives are addressing these challenges to help ensure that proposed solutions have the support of all involved stakeholders. |
| Databáze: | OpenAIRE |
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