Workshop report: USP workshop on exploring the science of drug absorption

Marilyn N. Martinez; Sid Bhoopathy; Sara Carlert; Murat Cirit; Raafat Fahmy; Talia Flanagan; Ben Forbes; Masoud Jamei; Mansoor A. Khan; Viera Lukacova; Jonathan P. Mochel; Xavier Pepin; Devendra Pade; Christos Reppas; Patrick J. Sinko; David Sperry; Konstantin Tsinman; Maria Vertzoni

doi:10.14227/DT260319P38

Workshop report: USP workshop on exploring the science of drug absorption

Marilyn N. Martinez^*, Sid Bhoopathy, Sara Carlert, Murat Cirit, Raafat Fahmy, Talia Flanagan, Ben Forbes, Masoud Jamei, Mansoor A. Khan, Viera Lukacova, Jonathan P. Mochel, Xavier Pepin, Devendra Pade, Christos Reppas, Patrick J. Sinko, David Sperry, Konstantin Tsinman, Maria Vertzoni

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

In October 2018, the United States Pharmacopeia (USP) hosted a two-day workshop to explore the science of drug absorption. Experts from around the globe presented some of the challenges associated with drug product development from the perspective of the physiological attributes of the patient (human or canine) and the body site for drug activity. Included in the discussions were methods and approaches for answering complex questions, providing insights into the strengths and challenges of methods available in our biopharmaceutical tool chest. The following is a synopsis of the presentations and the highlights of the discussions that ensued. Disclaimer: This article reflects the views of the authors and should not be construed as representing the views or policies of the United States Food and Drug Administration.

Original language	English
Pages (from-to)	38-66
Number of pages	29
Journal	Dissolution Technologies
Volume	26
Issue number	3
DOIs	https://doi.org/10.14227/DT260319P38
Publication status	Published - 1 Aug 2019

Keywords

Bioavailability
Bioequivalence
Formulation effects
In silico models
In vitro dissolution
In vitro systems
Interspecies differences
Oral drug absorption

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10.14227/DT260319P38

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Martinez, M. N., Bhoopathy, S., Carlert, S., Cirit, M., Fahmy, R., Flanagan, T., Forbes, B., Jamei, M., Khan, M. A., Lukacova, V., Mochel, J. P., Pepin, X., Pade, D., Reppas, C., Sinko, P. J., Sperry, D., Tsinman, K., & Vertzoni, M. (2019). Workshop report: USP workshop on exploring the science of drug absorption. Dissolution Technologies, 26(3), 38-66. https://doi.org/10.14227/DT260319P38

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title = "Workshop report: USP workshop on exploring the science of drug absorption",

abstract = "In October 2018, the United States Pharmacopeia (USP) hosted a two-day workshop to explore the science of drug absorption. Experts from around the globe presented some of the challenges associated with drug product development from the perspective of the physiological attributes of the patient (human or canine) and the body site for drug activity. Included in the discussions were methods and approaches for answering complex questions, providing insights into the strengths and challenges of methods available in our biopharmaceutical tool chest. The following is a synopsis of the presentations and the highlights of the discussions that ensued. Disclaimer: This article reflects the views of the authors and should not be construed as representing the views or policies of the United States Food and Drug Administration.",

keywords = "Bioavailability, Bioequivalence, Formulation effects, In silico models, In vitro dissolution, In vitro systems, Interspecies differences, Oral drug absorption",

author = "Martinez, {Marilyn N.} and Sid Bhoopathy and Sara Carlert and Murat Cirit and Raafat Fahmy and Talia Flanagan and Ben Forbes and Masoud Jamei and Khan, {Mansoor A.} and Viera Lukacova and Mochel, {Jonathan P.} and Xavier Pepin and Devendra Pade and Christos Reppas and Sinko, {Patrick J.} and David Sperry and Konstantin Tsinman and Maria Vertzoni",

year = "2019",

month = aug,

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doi = "10.14227/DT260319P38",

language = "English",

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Martinez, MN, Bhoopathy, S, Carlert, S, Cirit, M, Fahmy, R, Flanagan, T, Forbes, B, Jamei, M, Khan, MA, Lukacova, V, Mochel, JP, Pepin, X, Pade, D, Reppas, C, Sinko, PJ, Sperry, D, Tsinman, K & Vertzoni, M 2019, 'Workshop report: USP workshop on exploring the science of drug absorption', Dissolution Technologies, vol. 26, no. 3, pp. 38-66. https://doi.org/10.14227/DT260319P38

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AU - Bhoopathy, Sid

AU - Carlert, Sara

AU - Cirit, Murat

AU - Fahmy, Raafat

AU - Flanagan, Talia

AU - Forbes, Ben

AU - Jamei, Masoud

AU - Khan, Mansoor A.

AU - Lukacova, Viera

AU - Mochel, Jonathan P.

AU - Pepin, Xavier

AU - Pade, Devendra

AU - Reppas, Christos

AU - Sinko, Patrick J.

AU - Sperry, David

AU - Tsinman, Konstantin

AU - Vertzoni, Maria

PY - 2019/8/1

Y1 - 2019/8/1

N2 - In October 2018, the United States Pharmacopeia (USP) hosted a two-day workshop to explore the science of drug absorption. Experts from around the globe presented some of the challenges associated with drug product development from the perspective of the physiological attributes of the patient (human or canine) and the body site for drug activity. Included in the discussions were methods and approaches for answering complex questions, providing insights into the strengths and challenges of methods available in our biopharmaceutical tool chest. The following is a synopsis of the presentations and the highlights of the discussions that ensued. Disclaimer: This article reflects the views of the authors and should not be construed as representing the views or policies of the United States Food and Drug Administration.

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KW - Bioequivalence

KW - Formulation effects

KW - In silico models

KW - In vitro dissolution

KW - In vitro systems

KW - Interspecies differences

KW - Oral drug absorption

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Workshop report: USP workshop on exploring the science of drug absorption

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Keywords

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