Abstract
A randomized, parallel, active control, in vivo bioequivalence study (with clinical endpoint) determining the bioequivalence of two brands of dinoprostone 3 mg vaginal tablets was conducted in pregnant women at Jinnah Postgraduate Medical Center, Karachi. 3mg Dinoprostone vaginal tablet was administered with a second dose repeated after six hours if clinically prescribed. The bioequivalence was assessed by clinical endpoints and a safety analysis was also conducted for all dosed subjects. Maternal bishop score, CTG and neonatal APGAR score were noted. 90% Confidence Intervals for per protocol population was found well within the ±0.20 range. Test product (Glandin E2) and reference product (prostin E2) were found to be bioequivalent.
References
Naseem, Azra, et al. Intracervical Foley’s Catheter Balloon versus Prostaglandin E2 Vaginal Pessary for Induction of Labour. Journal of Rawalpindi Medical College (JRMC) 2007; 11(2): 94-98.
Ansar, Afia, et al. Comparison of misoprostol with Dinoprostone for induction of labour in postdated pregnancy. Journal of Surgery Pakistan (International) 2014; 19(1).
Harvey, Richard A, [ed.]. Lippincott's Illustrated Reviews: Pharmacology. 5th. Philadelphia: Lippincott Willims & Wilkins, a Wolters Kluwer Business 2012; p. 549.
Dissertations Online, Freie Universität Berlin. Fu Dissertations Online. [Online] [Cited: Feb 16, 2016.] http://www.diss.fu-berlin.de/diss/servlets/MCRFileNode Servlet/FUDISS_derivate_000000002802/1_chapter1.pdf?hosts.
Guidance for industry E6 Good clinical practice. consolidated guidance. s.l., USA: Centre for Drug evaluation and research, centre for biologic Evaluation and research, USA Department of health and Human services Food and drug administration, April 1996.
Summary product characteristics of Glandin E2 3mg vaginal tablet. Karachi, Pakistan: Nabiqasim Industries (Pvt) Ltd, 2013.
Draft guidance on Dinoprostone Gel, Food and drug admministration guidance. s.l., USA: USA office of generic drugs, United states of America, Sep 2011.
Draft guidance on Dinoprostone vaginal suppository, Food and drug administration guidance. s.l., USA: USA office of generic drugs, United State of America, June 2012.
Albar H, et al. The experience with prostaglandin E2 vaginal tablets for induction of labour in grand and great grand multiparae. A two year review in Saudi Arabia. Journal of Obstetrics nd Gynaecology 2000; 20(2): 132-135.
Taher SE, et al. Prostaglandin E2 vaginal gel or tablets for the induction of labour at term: a randomised controlled trial. An International Journal of Obstetrics and Gynaecology 2011; 719-725.
Waraich S, Naqvi Z. Comparsion of intravaginal isoprotrol and dinoprostone for induction of labour. Pakistan Journal of Surgery 2009; 25(3): 209-213.
Papanikolaou, Evangelos G, et al. Comparison of misoprostol and dinoprostone for elective induction of labour in nulliparous women at full term: a randomized prospective study. Reproductive Biology and Endocrinology 2004; 2: 70.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright (c) 2018 Haleema Yasmin, Ghazala Ishrat, Ghousia Saba, Sohaib Yahya, Najia Mansoor , Mohsin Ali