The development and validation of a generic instrument, QoDoS, for assessing the quality of decision making by Ronan Donelan, Stuart Walker, Sam Salek, Sam Salek

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Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices by Hasumati Rahalkar, Hasumati Rahalkar, Alan Sheppard, Sam Salek, Sam Salek

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Factors Influencing Delays in Patient Access to New Medicines in Canada: A Retrospective Study of Reimbursement Processes in Public Drug Plans by Sam Salek, Sam Salek, Sarah Lussier Hoskyn, Jeffrey Roy Johns, Nicola Allen, Chander Sehgal

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A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment? by Nicola Allen, Nicola Allen, Lawrence Liberti, Stuart R. Walker, Stuart R. Walker, Sam Salek, Sam Salek

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Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward by Nancy Ngum, Nancy Ngum, Jane Mashingia, Margareth Ndomondo-Sigonda, Stuart Walker, Stuart Walker, Sam Salek, Sam Salek

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Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry by Mercy Owusu-Asante, Mercy Owusu-Asante, Delese Mimi Darko, Stuart Walker, Stuart Walker, Sam Salek, Sam Salek

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Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries by Mercy Owusu-Asante, Mercy Owusu-Asante, Delese Mimi Darko, Stuart Walker, Stuart Walker, Sam Salek, Sam Salek

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Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for improvement by Nancy Ngum, Nancy Ngum, Jane Mashingia, Margareth Ndomondo-Sigonda, Stuart Walker, Stuart Walker, Sam Salek, Sam Salek

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South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access by Andrea Keyter, Sam Salek, Sam Salek, Lorraine Danks, Portia Nkambule, Boitumelo Semete-Makokotlela, Stuart Walker, Stuart Walker, Stuart Walker

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A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency by Andrea Keyter, Sam Salek, Shabir Banoo, Stuart Walker

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A Process for Evaluating Quality Decision-Making Practices During the Development, Review and Reimbursement of Medicines by Magdalena Bujar, Neil McAuslane, Stuart Walker, Sam Salek

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Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines by Hasumati Rahalkar, Hasumati Rahalkar, Hacer Coskun Cetintas, Sam Salek

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Two Minimal Clinically Important Difference (2MCID): A New Twist on an Old Concept by Faraz M. Ali, M. Sam Salek, Andrew Y. Finlay

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The Reliability and Relevance of a Quality of Decision Making Instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for Use During the Lifecycle of Medicines by Magdalena Bujar, Magdalena Bujar, Neil McAuslane, Stuart Walker, Stuart Walker, Sam Salek

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Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication? by Andrea Keyter, Andrea Keyter, Sam Salek, Shabir Banoo, Shabir Banoo, Stuart Walker, Stuart Walker

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The South African Regulatory System: Past, Present, and Future by Andrea Keyter, Andrea Keyter, Shabir Banoo, Shabir Banoo, Sam Salek, Stuart Walker, Stuart Walker

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The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland by Andrea Keyter, Andrea Keyter, Sam Salek, Shabir Banoo, Shabir Banoo, Stuart Walker, Stuart Walker

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Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review by Stefanie Ho Yi Chan, Yasmin Khatib, Sherael Webley, Deborah Layton, Deborah Layton, Deborah Layton, Sam Salek

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A Systematic Review of 207 Studies Describing Validation Aspects of the Dermatology Life Quality Index by Jui Vyas, Jeffrey R. Johns, Faraz M. Ali, John R. Ingram, Sam Salek, Andrew Y. Finlay

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Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial by Theresa Donhauser, Christian Apfelbacher, Gesina Kann, Clarissa Masur, Paul Kamudoni, Sam Salek, Christoph Abels, Michaela Gabes

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