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Akademický článek

Characterization of Plasma Protein Alterations in Pregnant and Postpartum Individuals Living With HIV to Support Physiologically-Based Pharmacokinetic Model Development.

Autor: Zhao S; Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Gockenbach M; Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Grimstein M; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Sachs HC; Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Mirochnick M; Boston University School of Medicine, Boston, MA, United States., Struble K; Division of Antivirals, Office of Antimicrobials, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Belew Y; Division of Antivirals, Office of Antimicrobials, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Wang J; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Capparelli EV; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, San Diego, CA, United States.; Pediatrics Department, School of Medicine, San Diego-Rady Children's Hospital San Diego, University of California, San Diego, San Diego, CA, United States., Best BM; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, San Diego, CA, United States.; Pediatrics Department, School of Medicine, San Diego-Rady Children's Hospital San Diego, University of California, San Diego, San Diego, CA, United States., Johnson T; Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Momper JD; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, San Diego, CA, United States., Maharaj AR; Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, BC, Canada.

Publikováno v: Frontiers in pediatrics [Front Pediatr] 2021 Oct 13; Vol. 9, pp. 721059. Date of Electronic Publication: 2021 Oct 13 (Print Publication: 2021).

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Akademický článek

Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019.

Autor: Khong YM; Abbvie Inc, North Chicago, IL 60064, USA. Electronic address: yuetmei.khong@abbvie.com., Liu J; Pfizer Inc, Groton, CT 06340, USA. Electronic address: jing.liu@pfizer.com., Cook J; Pfizer Inc, Groton, CT 06340, USA., Purohit V; Pfizer Inc, Groton, CT 06340, USA., Thompson K; Merck & Co., Inc, West Point, PA, USA., Mehrotra S; Otsuka Pharmaceutical Development & Commercialization, Princeton, NJ 08540, USA., Cheung SYA; Certara, Princeton, NJ 08650, USA., Hay JL; Medicines and Healthcare Products Regulatory Agency (MHRA), Canary Wharf, London E14 4PU, UK., Fletcher EP; U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Wang J; U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Sachs HC; U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Zhu H; U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Siddiqui A; U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Cunningham L; U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Selen A; U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.

Publikováno v: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2021 Jul; Vol. 164, pp. 66-74. Date of Electronic Publication: 2021 Apr 18.

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Akademický článek

Exposure-Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration.

Autor: Zhang Y; Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Khurana M; Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Sachs HC; Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Zhu H; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Burckart GJ; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Alexander J; Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Yao LP; Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wang J; Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2020 Jul; Vol. 108 (1), pp. 90-98. Date of Electronic Publication: 2020 Mar 16.

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