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The Role of Scientific Expertise in Generic Drug Development

Scientific expertise plays a crucial role in generic drug development, ensuring the same standards of quality, safety, and efficacy as brand-name drugs. Key areas where this expertise is essential include pharmacology, pharmacokinetics, bioequivalence, regulatory compliance, and formulation/process development. Notably, scientific affairs professionals play an important role in coordinating the different areas of expertise, highlighting the need for a deep understanding of the scientific principles underlying drug development.

Source: www.drugpatentwatch.com –

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