Global Regulatory And Biopharmaceutics Strategies In New Drug Development: Biowaivers
作者： Elora Gupta , Elizabeth Yamashita
DOI: 10.1007/978-1-4419-9216-1_8
关键词:
摘要: To minimize cost and development time, proactive strategies plans must be in place before embarking on pharmaceutical product process improvements, formulation changes line extensions. With escalating drug costs the need for reduced times, there has been increasing awareness within regulatory agencies as well industry, of to develop meaningful, discriminatory vitro tests that will help assure vivo bioavailability / bioequivalence (BA/BE). Assessing risk benefit criteria global requirements may include human studies or chemistry is a key component when determining ultimate contemplated changes.
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