FDA Bioequivalence Standards

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies,...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
Άλλοι συγγραφείς: Yu, Lawrence X. (Επιμελητής έκδοσης), Li, Bing V. (Επιμελητής έκδοσης)
Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
Γλώσσα:English
Έκδοση: New York, NY : Springer New York : Imprint: Springer, 2014.
Σειρά:AAPS Advances in the Pharmaceutical Sciences Series, 13
Θέματα:
Διαθέσιμο Online:Full Text via HEAL-Link
Πίνακας περιεχομένων:
  • 1 Bioequivalence History
  • 2 Fundamentals of Bioequivalence
  • 3 Basic Statistical Considerations
  • 4 The Effects of Food on Drug Bioavailability and Bioequivalence
  • 5 Bio waiver and Biopharmaceutics Classification System
  • 6 Bioequivalence of Highly Variable Drugs
  • 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
  • 8 Bioequivalence for Narrow Therapeutic Index Drugs
  • 9 Pharmacodynamic Endpoint-based Bioequivalence Studies
  • 10 Clinical Endpoint Bioequivalence Study
  • 11 Bioequivalence for Liposomal Drug Products
  • 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract
  • 13 Bioequivalence for Topical Drug Products
  • 14 Bioequivalence for Orally Inhaled and Nasal Drug Products
  • 15 Bioequivalence: Modeling and Simulation
  • 16 Bioanalysis.