NDLI: Pharmacokinetic modeling for evaluating dosing strategies of $anti-p185^{HER2}$ monoclonal antibodies

Content Provider	IEEE Xplore Digital Library
Author	Schoenhoff, Monika Maneval, Daniel Hutchins, Beth Blank, Greg Vetterlein, David Mordenti, Joyce Green, James
Copyright Year	1992
Description	Author affiliation: Department of Safety Evaluation, Genentech, Inc., 460 Point San Bruno Blvd, South San, Francisco, CA 94080 (Schoenhoff, Monika; Maneval, Daniel; Mordenti, Joyce; Green, James) \|\| Department of Medicinal and Analytical Chemistry, Genentech, Inc., 460 Point San Bruno Blvd, South San, Francisco, CA 94080 (Hutchins, Beth) \|\| Department of Process Recovery Research and Development, Genentech, Inc., 460 Point San Bruno Blvd, South San, Francisco, CA 94080 (Blank, Greg; Vetterlein, David)
Abstract	Pharmacokinetic modeling can be a valuable tool In the development of potential therapeutics. To Illustrate its use In evaluating dosing regimens, an example with monoclonal antibodies (MAb) directed against the extracellular domain of the protooncogene product $(p185^{HER2})$ is presented. Preclinical studies have shown that these MAb have an antiproliferative effect on tumors that overexpress $P185^{HER2}.$ Intact antibodies (4D5, HER2) or an antibody fragment (4D5 F(ab')2) were administered to female CD1 mice either Intravenously (IV) or intraperltoneally (IP), and single serum samples at scheduled times were collected after injection. Antibody concentrations were measured by ELISA. Serum time-course data were fitted to compartmental models, and model parameters were subsequently used to simulate serum antibody concentrations by Introducing multiple inputs to the central compartment. The 4D5 F(ab')2 cleared from the circulation much more rapidly (≈15 times) than the intact antibodies; therefore, the dosing schedule for 4D5 F(ab')2 would be different from Intact antibodies If the same target concentration Is to be achieved. In this study, the route of administration, IV or IP, did not greatly alter the systemic exposure of the molecule because IP absorption was relatively rapid and nearly complete.
Starting Page	2286
Ending Page	2287
File Size	151246
Page Count	2
File Format	PDF
ISBN	0780307852
DOI	10.1109/IEMBS.1992.5761465
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	1992-10-29
Publisher Place	France
Access Restriction	Subscribed
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	IP networks Mice
Content Type	Text
Resource Type	Article

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
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9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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