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The study was a prospective analysis of 25 healthy women undergoing IVF\/ICSI using gonadotropin\u2010releasing hormone (GnRH) antagonist protocol. The developed model used the FSH PK profiles to predict both inhibin B (first PD end point) and oocyte retrieval (second PD end point). The modeling framework involved 2 stages. First, the FSH\u2010inhibin B model was developed by the simultaneous approach and applied to estimate the individual area under the inhibin B\u2010time curve (AUC<jats:sub>Inhb<\/jats:sub>) at the end of stimulation cycles that varied in length in each woman. In the second stage, the estimated AUC<jats:sub>Inhb<\/jats:sub> was introduced as a link covariate to predict oocyte retrieval and response category. The population FSH\u2010inhibin B model was described as 3 submodels; PK (exogenous), endogenous, and inhibin B PD models. Weight was the main determinant of both endogenous and exogenous FSH exposures. GnRH antagonist therapy was a significant time\u2010varying covariate when tested against the endogenous FSH production rate (<jats:italic>P<\/jats:italic> &lt; .001). AUC<jats:sub>Inhb<\/jats:sub> could be predicted with women's age and weight. Log\u2010transformed AUC<jats:sub>Inhb<\/jats:sub> was a significant covariate when tested against oocyte retrieval (<jats:italic>P<\/jats:italic> &lt; .001). Simulations concluded a target AUC<jats:sub>Inhb<\/jats:sub> of 144\u2010303 ng\u00b7h\/mL for optimal ovarian response. The GnRH antagonist was better started on day 7 of the cycle. Covariate\u2010based dosing suggests lower recombinant follicle\u2010stimulating hormone requirements in a thin and\/or young population. An interactive web application \u201cGonadGuide\u201d was developed to facilitate the application in clinical practice.<\/jats:p>","DOI":"10.1002\/jcph.1792","type":"journal-article","created":{"date-parts":[[2020,12,4]],"date-time":"2020-12-04T08:36:28Z","timestamp":1607070988000},"page":"700-713","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Population PK\u2010PD\u2010PD Modeling of Recombinant Follicle Stimulating Hormone in In Vitro Fertilization\/Intracytoplasmic Sperm Injection: Implications on Dosing and Timing of Gonadotrophin Therapy"],"prefix":"10.1002","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9072-0815","authenticated-orcid":false,"given":"Abdel Hameed I. 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