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Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019.
Khong, Yuet Mei; Liu, Jing; Cook, Jack; Purohit, Vivek; Thompson, Karen; Mehrotra, Shailly; Cheung, S Y Amy; Hay, Justin L; Fletcher, Elimika Pfuma; Wang, Jian; Sachs, Hari Cheryl; Zhu, Hao; Siddiqui, Akhtar; Cunningham, Lea; Selen, Arzu.
Affiliation
  • 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.
Eur J Pharm Biopharm ; 164: 66-74, 2021 Jul.
Article in En | MEDLINE | ID: mdl-33878434
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Drug Development Limits: Child / Humans Language: En Journal: Eur J Pharm Biopharm Journal subject: FARMACIA / FARMACOLOGIA Year: 2021 Type: Article
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Drug Development Limits: Child / Humans Language: En Journal: Eur J Pharm Biopharm Journal subject: FARMACIA / FARMACOLOGIA Year: 2021 Type: Article