Hat mitgewirkt an:
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Going beyond the traditional BE borders : using in vitro and in silico tools to improve the assessment and extrapolation of therapeutic equivalence
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Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example:...
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Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review
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Physiologically based population pharmacokinetic/pharmacodynamic modeling and simulation approaches to support waivers of in vivo clinical pharmacology studies