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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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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 2011-03

PAT Slowly Yielding to Broader QbD

Angelo DePalma,

Genetic Engineering & Biotechnology News

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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 2017-11

Achieve QbD by Managing Impurity Data

Andrew Anderson, Graham A. McGibbon, Sanjivanjit K. Bhal

Genetic Engineering & Biotechnology News

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Research article

First published 2019-3

Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions

Nimita Limaye, Veena Jaguste

Therapeutic Innovation & Regulatory Science

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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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Case report

First published 2015-12

R (on the application of Gibraltar Betting and Gaming Association Ltd) v. Revenue and Customs Commissioners and Another [2015] EWHC 1863 (Admin),CO/4813/2014 (QBD,Administrative Court,July 14,2015)

Gaming Law Review

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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 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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