Sage Journals: Discover world-class research

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Research article

First published 2016-5

Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

Kiyohito Kuno, Satoshi Toyoshima

Therapeutic Innovation & Regulatory Science

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Research article

First published 2010-1

Opportunities and Challenges to Implementing Quality by Design Approach in Generic Drug Development

Ramaji K. Varu, Amit Khanna

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2014-5

USA FDA’s implementation of QbD and GDUFA: A wakeup call for other regulatory agencies across the globe

Manisha Saini, Swagat Tripathy, Harish Dureja

Journal of Medical Marketing: Device,Diagnostic and Pharmaceutical Marketing

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Review article

First published 2018-9

Implementation of Question-based Review in support of Quality by Design streamlining the US FDA’s review process

Alisha Desai, Jayanta Kumar Maji, Kanhoba Walavalkar [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2009-09

Quantitative Analysis and Design of a Spray Aerosol Inhaler. Part 1: Effects of Dilution Air Inlets and Flow Paths

P. Worth Longest, Michael Hindle

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Research article

First published 2013-08

Process Quality Engineering for Bioreactor-Driven Manufacturing of Tissue-Engineered Constructs for Bone Regeneration

Ioannis Papantoniou, Yoke Chin Chai, Frank P. Luyten [...]

Tissue Engineering Part C: Methods

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Research article

First published 2014-12

A Quality-by-Design Approach to Risk Reduction and Optimization for Human Embryonic Stem Cell Cryopreservation Processes

Peter D. Mitchell, Elizabeth Ratcliffe, Paul Hourd [...]

Tissue Engineering Part C: Methods

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Research article

First published 2011-11

A Bayesian Approach to Pharmaceutical Product Quality Risk Quantification

Linas Mockus, José Miguel Laínez, Gintaras Reklaitis [...]

Informatica: An International Journal of Computing and Informatics

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Review article

First published 2015-4

Accelerated Formulation Development of Monoclonal Antibodies (mAbs) and mAb-Based Modalities

Vladimir I. Razinkov, Michael J. Treuheit, Gerald W. Becker

Journal of Biomolecular Screening

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Editorial

First published 2024-4

Do medical devices contribute to sustainability? The role of innovative polymers and device design

Jörg Vienken, Carlo Boccato

The International Journal of Artificial Organs

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