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Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability.
Burmeister Getz, Elise; Carroll, Kevin J; Christopher, J David; Morgan, Beth; Haughie, Scott; Cavecchi, Alessandro; Wiggenhorn, Christopher; Beresford, Hayden; Strickland, Helen; Lyapustina, Svetlana.
Affiliation
  • Burmeister Getz E; Clinical Pharmacology, Sandoz Inc., 5959 Horton Street, Emeryville, California, 94608, USA. Elise.Burmeister-Getz@novartis.com.
  • Carroll KJ; KJC Statistics Limited, Cheshire, UK.
  • Christopher JD; Merck & Co., Inc., West Point, Pennsylvania, USA.
  • Morgan B; Inhaled Product Development, AstraZeneca, Durham, North Carolina, USA.
  • Haughie S; Biometrics-Global Clinical Operations, Viatris/Mylan Pharma UK Ltd., Sandwich, Kent, UK.
  • Cavecchi A; CMC-Quality Control & Product Development, Chiesi Farmaceutici S.p.A., Parma, Italy.
  • Wiggenhorn C; Research & Development, Kindeva Drug Delivery, St Paul, Minnesota, USA.
  • Beresford H; Formulation Development, Kindeva Drug Delivery, Loughborough, UK.
  • Strickland H; Manufacturing Science & Engineering, GlaxoSmithKline, Zebulon, North Carolina, USA.
  • Lyapustina S; Pharmaceutical Consortia Management Team, Faegre Drinker Biddle & Reath LLP, Washington, DC, USA.
AAPS PharmSciTech ; 22(7): 225, 2021 Aug 19.
Article in En | MEDLINE | ID: mdl-34410557
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Therapeutic Equivalency / Models, Statistical Type of study: Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Journal: AAPS PharmSciTech Journal subject: FARMACOLOGIA Year: 2021 Document type: Article Affiliation country: United States Country of publication: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Therapeutic Equivalency / Models, Statistical Type of study: Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Journal: AAPS PharmSciTech Journal subject: FARMACOLOGIA Year: 2021 Document type: Article Affiliation country: United States Country of publication: United States