Interaction of Mycophenolic Acid and Pantoprazole : A Pharmacokinetic Crossover Study

Intro -- Acknowledgements -- Summary -- Zusammenfassung -- List of Contents -- Figures -- Tables -- Abbreviations -- 1 Introduction -- 1.1 Mycophenolic Acid -- 1.1.1 Chemical Properties -- 1.2 Pharmacology of MPA -- 1.2.1 Pharmacokinetics of MPA -- 1.2.2 Pharmacokinetic Interactions of MPA -- 1.2.3 Clinical Aspects of MPA Pharmacokinetics -- 1.2.4 Pharmacodynamics of MPA -- 1.3 Analytical Aspects of MPA Measurement and Its Metabolites -- 1.3.1 Sample Preparation -- 1.3.2 Chromatography -- 1.3.3 Stability -- 1.3.4 Assays for Determination of MPA and Its Metabolites -- 1.4 Pharmacology of Pantoprazole -- 2 Research Objectives -- 3 Materials -- 3.1 Chemicals -- 3.2 Kits -- 3.3 Consumable Material -- 3.4 Hardware and Software -- 3.4.1 Hardware -- 3.4.2 Software -- 4 Methods -- 4.1 Quantification of MPA and MPAG in Human Plasma -- 4.1.1 Sample Preparation -- 4.2 Measurement of IMPDH Activity -- 4.3 Validation Conditions -- 4.3.1 Preparation of Calibration and Quality Control Standards -- 4.3.2 Selectivity -- 4.3.3 Limit of Detection -- 4.3.4 LLOQ -- 4.3.5 Linearity -- 4.3.6 Bias and Precision -- 4.3.7 Carry-Over -- 4.3.8 Dilution Integrity -- 4.3.9 Extraction Recovery -- 4.3.10 Method Comparison -- 4.3.11 Stability -- 4.4 PK/PD Study about an Interaction of Pantoprazole and Mycophenolic Acid -- 4.4.1 Study Description -- 4.4.2 Inclusion and Exclusion Criteria -- 4.4.3 Sample Pre-Treatment and Laboratory Analysis -- 4.4.4 Pharmacokinetic and Pharmacodynamic Analysis -- 4.4.5 Data Evaluation and Statistical Analysis -- 4.4.6 Sample Size Calculations -- 4.4.7 Descriptive Analysis -- 5 Results -- 5.1 Validation of an HPLC-UV Assay for Quantification of MPA and MPAG in Human Plasma -- 5.1.1 Limit of Detection -- 5.1.2 Selectivity -- 5.1.3 Linearity -- 5.1.4 Accuracy -- 5.1.5 Carry-Over -- 5.1.6 Dilution Integrity -- 5.1.7 Extraction Recovery.

5.1.8 Method Comparison -- 5.1.9 Stability -- 5.2 PK/PD Study about an Interaction of Pantoprazole and Mycophenolic Acid -- 5.2.1 Analytical Aspects of Study Samples Measurement -- 5.2.2 Statistical Considerations for Sample Size Calculation -- 5.2.3 Demographics -- 5.2.4 Adverse Events -- 5.2.5 Pharmacokinetics of MPA -- 5.2.6 Pharmacokinetics of MPAG -- 5.2.7 Pharmacodynamics of MPA -- 6 Discussion -- 6.1 Quantification of MPA and MPAG in Human Plasma -- not -- 6.1.1 Sample Preparation -- 6.1.2 Chromatographic Conditions -- 6.1.3 Validation Parameters -- 6.1.4 Method Comparison -- 6.1.5 Stability -- 6.1.6 Conclusion and Final Remarks -- 6.2 PK/PD Study about an Interaction of Pantoprazole and Mycophenolic Acid -- 6.2.1 Pharmacokinetics of MPA after EC-MPS and MMF Intake -- 6.2.2 Influence of Pantoprazole on MPA Pharmacokinetics -- 6.2.3 Influence of Pantoprazole on MPAG Pharmacokinetics -- 6.2.4 Influence of Pantoprazole on IMPDH Activity -- 6.2.5 Proton Pump Inhibitors and Their Clinical Role in MPA Treatment -- 6.2.6 Limitations of the PK/PD Study -- 6.2.7 Conclusion and Final Remarks -- 7 References -- 8 Appendix -- 8.1 Short-Term Stability Analysis of Unprocessed Lithium-Heparin Blood at Room Temperature -- 8.2 Demographics of All Patients in the PK/PD Study to Investigate the Interaction of Pantoprazole and MPA -- 8.3 LMEM Results of the PK/PD Study on the Interaction of Pantoprazole and Mycophenolic Acid -- 8.3.1 LMEM Syntax for Evaluation of MPA, MPAG Pharmacokinetics and MPA Pharmacodynamics -- 8.3.2 LMEM Output of MPA Pharmacokinetics after MPA±PAN Intake -- 8.3.3 LMEM Output of MPAG pharmacokinetics after MPA±PAN Intake -- 8.3.4 LMEM Output of MPA Pharmacodynamics after MPA±PAN Intake.

Medienart:	E-Book

Erscheinungsjahr:	2017
Erschienen:	Wiesbaden: Spektrum Akademischer Verlag ; 2017

Sprache:	Englisch

Beteiligte Personen:	Rissling, Olesja [VerfasserIn]

Links:	Volltext [lizenzpflichtig]

ISBN:	978-3-658-19889-3

Themen:	Drug interactions Electronic books Mycophenolic acid Mycophenolic acid..

Umfang:	1 Online-Ressource (177 pages)

Förderinstitution / Projekttitel:

PPN (Katalog-ID):	1046140493