Abstract
The assessment of a drug’s bioavailability (BA) is the most important information on its pharmacokinetics. Consequently, numerous guidelines primarily focus on this issue as from the exposure efficacy as well as safety for the patient (Study Design et al. 2003; ICH E4: Dose–Response Information to Support Drug Registration March 1994; EU CPMP: Note for Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Pharmacokinetic and Clinical Evaluation) July 1999; EU CPMP: Note for Guidance on the Investigation of Bioavailability and Bioequivalence July 2001; US FDA Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies December 2002; US FDA Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations March 2003; US FDA Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action April 2003; EU CPMP: Points to Consider on the Clinical Requirements of Modified Release Products to be Submitted as a Line Extension of an Existing Marketing Authorization June 2003).
Keywords
- Pharmacokinetic Parameter
- Oral Formulation
- Relative Bioavailability
- Oral Solution
- Capsule Formulation
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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Wesch, R. (2011). Absolute and Relative Bioavailability. In: Vogel, H.G., Maas, J., Gebauer, A. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-89891-7_16
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DOI: https://doi.org/10.1007/978-3-540-89891-7_16
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-89890-0
Online ISBN: 978-3-540-89891-7
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