Population pharmacokinetics of 17alpha-hydroxyprogesterone caproate in singleton gestation. (Record no. 3005)

MARC details
000 -LEADER
fixed length control field 03061nam a22004337a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 170411s20162016 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0306-5251
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 27133963
245 ## - TITLE STATEMENT
Title Population pharmacokinetics of 17alpha-hydroxyprogesterone caproate in singleton gestation.
251 ## - Source
Source British Journal of Clinical Pharmacology. 82(4):1084-93, 2016 Oct
252 ## - Abbreviated Source
Abbreviated source Br J Clin Pharmacol. 82(4):1084-93, 2016 Oct
253 ## - Journal Name
Journal name British journal of clinical pharmacology
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2016
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2017
266 ## - Date added to catalog
Date added to catalog 2017-05-24
520 ## - SUMMARY, ETC.
Abstract AIMS: 17alpha-hydroxyprogesterone caproate (17-OHPC) reduces the rate of preterm birth in women with a prior preterm birth. Limited data exist on the pharmacokinetics (PK) of 17-OHPC or the plasma concentrations achieved during therapy. In this study, we evaluated the population PK of 17-OHPC in pregnant subjects with singleton gestation and also evaluated intrinsic and extrinsic factors that may potentially affect 17-OHPC PK in this patient population.
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: The population PK study reported here represents the initial steps in understanding and optimizing 17-OHPC therapy for preventing preterm birth.
520 ## - SUMMARY, ETC.
Abstract Copyright � 2016 The British Pharmacological Society.
520 ## - SUMMARY, ETC.
Abstract METHODS: Sixty-one women with singleton pregnancies participated in this trial. Subjects received weekly intramuscular injections of 250 mg 17-OHPC in 1 ml castor oil from the time of enrolment (16 0/7 weeks - 20 6/7 weeks) up to 35 weeks gestation or until delivery. Blood samples were obtained between 24 and 28 weeks, between 32 and 35 weeks and over a 28-day period beyond the last injection. Maternal and/or cord blood were obtained at delivery. Data analysis was performed by nonlinear mixed effects modelling (NONMEM() ).
520 ## - SUMMARY, ETC.
Abstract RESULTS: The 17-OHPC PK were best described by a model with one maternal compartment and one fetal compartment, with first-order absorption and elimination from the maternal compartment. Maternal body weight was a significant covariate for both clearance (CL/F) and volume of distribution (Vmaternal /F). The final population mean estimates were: CL/F 1797 l/d, Vmaternal /F 32 610 l and mother to cord rate constant 0.005 day(-1) . This report describes for the first time the population PK of 17-OHPC in singleton pregnancy.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Hydroxyprogesterones/pk [Pharmacokinetics]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adult
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Body Weight
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Fetal Blood
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Hydroxyprogesterones/bl [Blood]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Models, Biological
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pregnancy
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Young Adult
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Health Research Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Miodovnik, Menachem
790 ## - Authors
All authors Caritis S, Hankins G, Hebert MF, Mattison D, Miodovnik M, Sharma S, Venkataramanan R
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1111/bcp.12990">https://dx.doi.org/10.1111/bcp.12990</a>
Public note https://dx.doi.org/10.1111/bcp.12990
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Date last checked out Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 05/24/2017 1 27133963 27133963 09/26/2017 09/26/2017 05/24/2017 Journal Article

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