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Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future OutlookNARA Subscribed
Pharmaceutical Research · 2025 · Vol. 42 · Issue 5 · Springer
Sivacharan Kollipara; Markus Friden; Tycho Heimbach; Pratik Saha; Jan De Backer; Tausif Ahmed; Timothy Nicholas
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Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug ProductsNARA Subscribed
Pharmaceutical Research · 2025 · Vol. 42 · Issue 5 · Springer
Ross L. Walenga; Khondoker Alam; James F. Clarke; Jan De Backer; Markus Fridén; Abdullah Hamadeh; Jay Mowli; Sujatha Sonti; Jessica Spires; Ming-Liang Tan; Flora T. Musuamba; Eleftheria Tsakalozou
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Leveraging Model Master Files from a Technology Company Perspective: Facilitating Quantitative Medicine in Regulatory FrameworksNARA Subscribed
Pharmaceutical Research · 2025 · Vol. 42 · Issue 5 · Springer
Jan De Backer; James Clarke; Hosein Sadafi; William Ganley; Jessica Spires
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Comparative study of traditional and DNA-based methods for environmental impact assessment: A case study of marine aggregate extraction in the North SeaNARA Subscribed
Science of The Total Environment · 2024 · Vol. 946 · Elsevier
Van den Bulcke Laure; De Backer Annelies; Hillewaert Hans; Maes Sara; Seghers Stephie; Waegeman Willem; Wittoeck Jan; Hostens Kris; Derycke Sofie
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Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug ProductsNARA Subscribed
The AAPS Journal · 2024 · Vol. 26 · Issue 1 · Springer
Ross L. Walenga; Andrew H. Babiskin; Sid Bhoopathy; James F. Clarke; Jan De Backer; Murray Ducharme; Marc Kelly; Maxime Le Merdy; Miyoung Yoon; Partha Roy
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Understanding the impact of sand extraction on benthic ecosystem functioning: a combination of functional indices and biological trait analysisOA Marine
Frontiers in Marine Science · 2023 · Vol. 10 · Frontiers
Nanou Goedefroo; Ulrike Braeckman; Kris Hostens; Jan Vanaverbeke; Tom Moens; Annelies De Backer
Marine aggregates have been intensively extracted in the North-East Atlantic over the past decades. This study aimed to assess the effect of sand extraction on benthic ecosystem functioning using a combination of biological traits and functional indices (the bioturbation (BP c ) and irrigation potential (IP c ) and secondary production (SP c ) of the macrobenthic community). Data on macrobenthos, sediment properties and extrac...
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Increased food availability at offshore wind farms affects trophic ecology of plaice Pleuronectes platessaNARA Subscribed
Science of The Total Environment · 2023 · Vol. 862 · Elsevier
Jolien Buyse; Kris Hostens; Steven Degraer; Marleen De Troch; Jan Wittoeck; Annelies De Backer
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Detection of Macrobenthos Species With Metabarcoding Is Consistent in Bulk DNA but Dependent on Body Size and Sclerotization in eDNA From the Ethanol PreservativeOA Marine
Frontiers in Marine Science · 2021 · Vol. 8 · Frontiers
Sofie Derycke; Sara Maes; Laure Van den Bulcke; Joran Vanhollebeke; Jan Wittoeck; Hans Hillewaert; Bart Ampe; Annelies Haegeman; Kris Hostens; Annelies De Backer
DNA metabarcoding is a promising method to increase cost and time efficiency of marine monitoring. While substantial evidence exists that bulk DNA samples adequately reflect diversity patterns of marine macrobenthos, the potential of eDNA in the ethanol preservative of benthic samples for biodiversity monitoring remains largely unexplored. We investigated species detection in bulk DNA and eDNA from the ethanol preservative in...
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Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation ProductsNARA Subscribed
The AAPS Journal · 2015 · Vol. 17 · Issue 3 · Springer
Leslie Hendeles; Peter T. Daley-Yates; Robert Hermann; Jan De Backer; Sanjeeva Dissanayake; Stephen T. Horhota
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