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Expediting Patients' Access to Medicines by Improving the Predictability of Drug Development and the Regulatory Approval Process
Author(s) -
Liberti L,
Breckenridge A,
Eichler H G,
Peterson R,
McAuslane N,
Walker S
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.179
Subject(s) - expediting , drug development , clinical pharmacology , regulatory science , risk analysis (engineering) , drug approval , business , access to medicines , process (computing) , medicine , drug , process management , pharmacology , computer science , engineering , systems engineering , pathology , operating system , nursing , public health
Ideally, well‐designed global pharmaceutical development programs that include simultaneous submissions to multiple regulatory agencies can result in predictable regulatory approvals and expedited access to medicines for all patients. The workshops described herein investigated current trends in development and submission strategies along with regulatory review performance data in order to consider whether barriers to predictable expedited approval outcomes can be overcome through innovative clinical development approaches and a better understanding of review processes and procedures, particularly as these relate to the assessment of a product's risk–benefit profile. Clinical Pharmacology & Therapeutics (2010) 87 1, 27–31. doi: 10.1038/clpt.2009.179