Items where Author is "Salek, Sam"

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Article

Guidelines for the Use and Reporting of Patient-Reported Outcomes in Multiple Myeloma Clinical Trials. (2023) Edward Laane, Sam Salek, Esther Natalie Oliva, Christine Bennink, Solène Clavreul, Paul G Richardson, Christof Scheid, Katja Weisel and Tatyana Ionova

Psychometric validation of the Pyruvate Kinase Deficiency Diary and Pyruvate Kinase Deficiency Impact Assessment in adults in the phase 3 ACTIVATE trial. (2023) David A. Andrae, RF Grace, Adrian Jewett, Brandon Foster, Robert J. Klaassen, Sam Salek, Junlong Li, Feng Tai, Audra N. Boscoe and Erin Zagadailov

Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities. (2023) Lorraine Danks, Boitumelo Semete-Makokotlela, Kennedy Otwombe, Yashmika Parag, Stuart Walker and Sam Salek

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. (2023) Theresa Donhauser, Christian Apfelbacher, Gesina Kann, Clarissa Masur, Paul Kamudoni, Sam Salek, Christoph Abels and Michaela Gabes

Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening. (2023) Jane Mashingia, Nancy Ngum, Margareth Ndomondo-Sigonda, Adem Kermad, Magda Bujar, Sam Salek and Stuart Walker

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry. (2023) Mercy Owusu-Asante, Delese Mimi Darko, Stuart Walker and Sam Salek

Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities. (2023) Mercy Owusu-Asante, Delese Mimi Darko, Kwame Dei Asamoah-Okyere, Samuel Asante-Boateng, Adem Kermad, Stuart Walker and Sam Salek

A cross‐sectional study of the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across the Middle East and Africa ( PACT‐MEA ): Study design and rationale. (2023) Subodh Verma, Hani Sabbour, Naji Alamuddin, Fatheya Alawadi, Hessa Alkandari, Wael Almahmeed, Samir H. Assaad‐Khalil, Jihad Haddad, Landman Lombard, Rayaz A. Malik, Emel Mashaki Ceyhan, Preethy Prasad, Gamze Tombak and Sam Salek

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries. (2022) Mercy Owusu-Asante, Delese Mimi Darko, Stuart Walker and Sam Salek

Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for improvement. (2022) Nancy Ngum, Jane Mashingia, Margareth Ndomondo-Sigonda, Stuart Walker and Sam Salek

Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward. (2022) Nancy Ngum, Jane Mashingia, Margareth Ndomondo-Sigonda, Stuart Walker and Sam Salek

The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis. (2022) Paul Kamudoni, Dagmar Amtmann, Jeffrey Johns, Karon F. Cook, Rana Salem, Sam Salek, Jana Raab, Rod Middleton, Pavle Repovic, Kevin N. Alschuler, Gloria von Geldern, Annette Wundes, Amy Barrett, Oyebimpe Olayinka-Amao and Christian Henke

Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward. (2022) Tariro Sithole, Gugu Mahlangu, Stuart Walker and Sam Salek

Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward. (2022) Tariro Sithole, Gugu Mahlangu, Stuart Walker and Sam Salek

Comparison of the registration process of the Medicines Control Authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: Benchmarking best practices. (2021) Tariro Sithole, Sam Salek, Gugu Mahlangu and Stuart Walker

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities. (2021) Hasumati Rahalkar, Alan Sheppard, Gustavo Mendes Lima Santos, Chitralekha Dasgupta, Sonia Mayra Perez-Tapia, Carlos A. Lopez-Morales and Sam Salek

Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. (2021) Tariro Sithole, Gugu Mahlangu, Velma Capote, Tania Sitoie, Saren Shifotoka, Johannes Gaeseb, Silverani Padayachee, Tohlang Sehloho, Akida Khea, Adam Fimbo, Zuma Munkombwe, Bernice Mwale, Sam Salek and Stuart Walker

Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. (2021) Tariro Sithole, Gugu Mahlangu, Velma Capote, Tania Sitoie, Saren Shifotoka, Johannes Gaeseb, Lorraine Danks, Portia Nkambule, Alex Juma, Adam Fimbo, Zuma Munkombwe, Bernice Mwale, Sam Salek and Stuart Walker

Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices. (2021) Hasumati Rahalkar, Alan Sheppard and Sam Salek

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access. (2021) Andrea Keyter, Sam Salek, Lorraine Danks, Portia Nkambule, Boitumelo Semete-Makokotlela and Stuart Walker

Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization of Biosimilar Medicines in BRICS-TM Countries: An Exploratory Study. (2021) Hasumati Rahalkar, Alan Sheppard, Carlos Augusto Lopez-Morales, Luciano Lobo and Sam Salek

Development of a Novel Hematological Malignancy Specific Patient-Reported Outcome Measure (HM-PRO) : Content Validity. (2020) Pushpendra Goswami, Esther Oliva, Tatyana Ionova, R Else, J Kell, AK Fielding, DM Jennings, M Karakantza, S Al-Ismail, GP Collins, S McConnell, Catherine Langton and Sam Salek

Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies. (2020) M Bujar, N McAuslane, Walker Stuart and Sam Salek

Development of the Pyruvate Kinase Deficiency Diary (PKDD) and Pyruvate Kinase Deficiency Impact Assessment (PKDIA): Disease-Specific Assessments. (2019) Sam Salek

A comparison of reimbursement recommendations by European HTA agencies : Is there opportunity for further alignment? (2017) Nicola Allen, Lawrence Liberti, Stuart R. Walker and Sam Salek

Health Technology Assessment (HTA) Case Studies : Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland. (2017) Nicola Allen, Stuart R Walker, Lawrence Liberti and Sam Salek

Other

Development of a Consumer Reported Outcome Measure for Personal Care Products : The Rationale. (2024) Robert Falcone, Nikkie Umaru, Bozena michniak-kohn and Sam Salek

Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review. (2023) Stefanie Ho Yi Chan, Yasmin Khatib, Sherael Webley, Deborah Layton and Sam Salek

The Reporting, Use, and Validity of Patient-Reported Outcomes in Multiple Myeloma in Clinical Trials: A Systematic Literature Review. (2022) Sam Salek, Tatiana Ionova, Esther Natalie Oliva, Marike Andreas, Nicole Skoetz, Nina Kreuzberger and Edward Laane

Haematological malignancy: are we measuring what is important to patients? A systematic review of quality of life instruments. (2019) Pushpendra Goswami, Yasmin Khatib and Sam Salek