Pharmacokinetic Prodrug Modeling: In Vitro and In Vivo Kinetics and Mechanisms of Ancitabine Bioconversion to Cytarabine

1984 ◽  
Vol 73 (6) ◽  
pp. 728-732 ◽  
Author(s):  
Lee E. Kirsch ◽  
Robert E. Notari
Keyword(s):  
2021 ◽  
Vol 65 (9) ◽  
pp. 2170020
Author(s):  
Jing Jin ◽  
Albertus Spenkelink ◽  
Karsten Beekmann ◽  
Marta Baccaro ◽  
Fuguo Xing ◽  
...  

Materials ◽  
2021 ◽  
Vol 14 (3) ◽  
pp. 555
Author(s):  
Marilena Vlachou ◽  
Vangelis Karalis

The aim of this study was to develop a new in vitro–in vivo simulation (IVIVS) approach in order to predict the outcome of a bioequivalence study. The predictability of the IVIVS procedure was evaluated through its application in the development process of a new generic product of amlodipine/irbesartan/hydrochlorothiazide. The developed IVIVS methodology is composed of three parts: (a) mathematical description of in vitro dissolution profiles, (b) mathematical description of in vivo kinetics, and (c) development of joint in vitro–in vivo simulations. The entire programming was done in MATLAB® and all created scripts were validated through other software. The IVIVS approach can be implemented for any number of subjects, clinical design, variability and can be repeated for thousands of times using Monte Carlo techniques. The probability of success of each scenario is recorded and finally, an overall assessment is made in order to select the most suitable batch. Alternatively, if the IVIVS shows reduced probability of BE success, the R&D department is advised to reformulate the product. In this study, the IVIVS approach predicted successfully the BE outcome of the three drugs. During the development of generics, the IVIVS approach can save time and expenses.


2009 ◽  
Vol 25 (2) ◽  
pp. 105-112 ◽  
Author(s):  
Samantha Carreiro ◽  
Scott Anderson ◽  
Hovhannes J. Gukasyan ◽  
Achim Krauss ◽  
Ganesh Prasanna

2021 ◽  
pp. 2001085
Author(s):  
Jing Jin ◽  
Albertus Spenkelink ◽  
Karsten Beekmann ◽  
Marta Baccaro ◽  
Fuguo Xing ◽  
...  

1980 ◽  
Vol 17 (4) ◽  
pp. 295-299 ◽  
Author(s):  
A. Melander ◽  
B. Hallengren ◽  
S. Rosendal-Helgesen ◽  
A. -K. Sj�berg ◽  
E. W�hlin-Boll

1981 ◽  
Vol 99 (3) ◽  
pp. 463-466 ◽  
Author(s):  
Milap C. Nahata ◽  
Pharm D. ◽  
Dwight A. Powell ◽  
John P. Glazer ◽  
Milo D. Hilty

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