Author
Number of items: 65.
Article
Cancer-Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK Yellow Card Adverse Drug Reaction (ADR) Reporting. (2024)
Stefanie Ho Yi Chan,
Deborah Layton,
Sherael Webley
and
Sam Salek
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Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16). (2024)
R. Shah,
A.Y. Finlay,
M.S. Salek,
H. Allen,
S.J. Nixon,
M. Nixon,
K. Otwombe,
F.M. Ali
and
J.R. Ingram
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Development of a Consumer Reported Outcome Measure for Personal Care Products : The Rationale. (2024)
Robert Falcone,
Nikkie Umaru,
Bozena michniak-kohn
and
Sam Salek
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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
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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
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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
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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
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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. (2023)
Theresa Donhauser,
Christian Apfelbacher,
Gesina Kann,
Clarissa Masur,
Paul Kamudoni,
Sam Salek,
Christoph Abels
and
Michaela Gabes
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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
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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. (2023)
Mercy Owusu-Asante,
Delese Mimi Darko,
Stuart Walker
and
Sam Salek
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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
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Meaning of Family Reported Outcome Measure (FROM-16) severity score bands: a cross-sectional online study in the UK. (2023)
Rubina Shah,
Andrew Y Finlay,
Sam M Salek,
Stuart J Nixon,
Kennedy Otwombe,
Faraz M Ali
and
John R Ingram
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices. (2021)
Hasumati Rahalkar,
Alan Sheppard
and
Sam Salek
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Family reported outcomes, an unmet need in the management of a patient's disease: appraisal of the literature. (2021)
Rubina Shah,
F. M. Ali,
A. Y. Finlay
and
M. S. Salek
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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
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Clinical experience and psychometric properties of the Cardiff Acne Disability Index (CADI). (2021)
Y.T. Abdelrazik,
F.M. Ali,
M.S. Salek
and
A.Y. Finlay
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Measuring the impact of COVID-19 on the quality of life of the survivors, partners and family members: a cross-sectional international online survey. (2021)
Rubina Shah,
Faraz M Ali,
Stuart J Nixon,
John R Ingram,
Sam M Salek
and
Andrew Y Finlay
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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
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Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies. (2020)
M Bujar,
N McAuslane,
Walker Stuart
and
Sam Salek
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Development of the Pyruvate Kinase Deficiency Diary (PKDD) and Pyruvate Kinase Deficiency Impact Assessment (PKDIA): Disease-Specific Assessments. (2019)
Sam Salek
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Validation of the electronic Psoriasis Area and Severity Index application : Establishing measurement equivalence. (2019)
Faraz Mahmood Ali,
Mir-Saeed Shayegan Salek,
Andrew Y. Finlay
and
Vincent Piguet
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Presenting signs and patient co-variables in Gaucher disease : outcome of the Gaucher Earlier Diagnosis Consensus (GED-C) Delphi initiative. (2019)
Atul Mehta,
David Kuter,
Mir-Saeed Shayegan Salek,
N Belmatoug,
B Bembi,
J Bright,
S Vom Dahl,
F Deodato,
M Di Rocco,
O Goker-Alpan,
DA Hughes,
EA Lukina,
M Machaczka,
E Mengel,
A Nagral,
K Nakamura,
A Narita,
B Oliveri,
G Pastores,
J Pérez-López,
U Ramaswami,
IV Schwartz,
J Szer,
NJ Weinreb
and
A Zimran
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Paper and electronic versions of HM-PRO, a novel patient-reported outcome measure for hematology: an equivalence study. (2019)
Pushpendra Goswami,
Esther Oliva,
Tatyana Ionova,
R Else,
J Kell,
AK Fielding,
DM Jennings,
M Karakantza,
S Al-Ismail,
J Lyness,
GP Collins,
S McConnell,
C Langton,
MJ Al-Obaidi,
M Oblak
and
Mir-Saeed Shayegan Salek
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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
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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. (2019)
Mir-Saeed Shayegan Salek,
Sarah Lussier Hoskyn,
Jeffrey Johns,
Nicola Allen
and
Chander Sehgal
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The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland. (2019)
Andrea Keyter,
Mir-Saeed Shayegan Salek,
Shabir Banoo
and
Stuart R. Walker
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Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications. (2019)
Mir-Saeed Shayegan Salek,
Sarah Lussier Hoskyn,
Jeffrey Johns,
Nicola Allen
and
Chander Sehgal
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Validation of the Thai version of the family reported outcome measure (FROM-16)© to assess the impact of disease on the partner or family members of patients with cancer. (2019)
Pattariya Chantarasap,
Nutjaree Johns,
Srivieng Pairojkul,
Aumkhae Sookprasert,
Kosin Wirasorn,
Areewan Cheawchanwattana,
Mir-Saeed Shayegan Salek
and
Suphat Subongkot
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The South African Regulatory System: Past, Present, and Future. (2018)
A Keyter,
Shabir Banoo,
Mir-Saeed Shayegan Salek
and
Stuart R. Walker
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The Burden of Disease in Pyruvate Kinase Deficiency: Patients' Perception of the Impact on Health-Related Quality of Life. (2018)
RF Grace,
L Cohen,
S Egan,
T Wells,
B Witherspoon,
A Ryan,
Mir-Saeed Shayegan Salek,
S Bodie
and
RJ Klaassen
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Appraisal of patient-reported outcome measures in analogous diseases and recommendations for use in phase II and III clinical trials of pyruvate kinase deficiency. (2018)
Mir-Saeed Shayegan Salek,
Tatyana Ionova,
Jeffrey Johns
and
Esther Natalie Oliva
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Correlating the Dermatology Life Quality Index with psychiatric measures: A systematic review. (2018)
FM Ali,
Nutjaree Johns,
Mir-Saeed Shayegan Salek
and
Andrew Y. Finlay
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Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines. (2018)
Hasumati Rahalkar,
Hacer Coskun Cetintas
and
Mir-Saeed Shayegan Salek
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Occurrence, Chronicity and Intensity of Itch in a Clinical Consecutive Sample of Patients with Skin Diseases: a Multi-centre Study in 13 European Countries. (2018)
Christina Schut,
F J Dalgard,
Jon Anders Halvorsen,
Uwe Gieler,
Lars Lien,
L Tomás-Aragonés,
Francoise Poot,
Gregor B.E. Jemec,
Laurent Misery,
L Kemeny,
Francesca Sampogna,
Henriët Van Middendorp,
Flora Balieva,
Dennis Linder,
Jacek C Szepietowski,
A Lvov,
SE Marron,
Ilknur K. Altunay,
Andrew Y. Finlay,
Mir-Saeed Shayegan Salek
and
Joerg Kupfer
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The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System. (2018)
A Keyter,
J Gouws,
Mir-Saeed Shayegan Salek
and
S Walker
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The Role of Therapy in Impairing Quality of Life in Dermatological Patients: A Multinational Study. (2018)
Flora Balieva,
Andrew Y. Finlay,
Joerg Kupfer,
Lucia Tomas-Aragones,
Lars Lien,
Uwe Gieler,
Francoise Poot,
Gregor B.E. Jemec,
Laurent Misery,
L Kemeny,
Francesca Sampogna,
Henriët Van Middendorp,
Jon Anders Halvorsen,
T Ternowitz,
Jacek C. Szepietowski,
N Potekaev,
SE Marron,
Ilknur K. Altunay,
Mir-Saeed Shayegan Salek
and
Florence Dalgard
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Two Minimal Clinically Important Difference (2MCID) : A New Twist on an Old Concept. (2018)
Faraz M Ali,
M Sam Salek
and
Andrew Finlay
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Mapping of the DLQI scores to EQ-5D utility values using ordinal logistic regression. (2017)
Faraz Mahmood Ali,
Richard Kay,
Andrew Y. Finlay,
Vincent Piguet,
Joerg Kupfer,
Florence Dalgard
and
M. Sam Salek
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Determinants of Psychosocial Health in Psoriatic Patients: A Multinational Study. (2017)
Karolina Lesner,
Adam Reich,
Jacek C Szepietowski,
Florence Dalgard,
Andrew Y. Finlay,
Joerg Kupfer,
Uwe Gieler
and
Mir-Saeed Shayegan Salek
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Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment : A Systematic Review of the Literature. (2017)
M Bujar,
N McAuslane,
S Walker
and
Mir-Saeed Shayegan Salek
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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
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A systematic review of the use of quality-of-life instruments in randomized controlled trials for psoriasis. (2017)
F M Ali,
A C Cueva,
J Vyas,
A A Atwan,
M S Salek,
A Y Finlay
and
V Piguet
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Understanding clinician influences and patient perspectives on outpatient discharge decisions : A qualitative study. (2017)
N. A. Harun,
A. Y. Finlay,
V. Piguet
and
S. Salek
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Evaluating alignment between Canadian Common Drug Review reimbursement recommendations and provincial drug plan listing decisions : an exploratory study. (2016)
Nicola Allen,
Stuart R Walker,
Lawrence Liberti,
Chander Sehgal
and
M Sam Salek
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Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective. (2016)
Kirstie Haywood,
Anne Lyddiatt,
Samantha J. Brace-McDonnell,
Sophie Staniszewska
and
Mir-Saeed Shayegan Salek
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Impairment of Sexual Life in 3,485 Dermatological Outpatients From a Multicentre Study in 13 European Countries. (2016)
Francesca Sampogna,
D Abeni,
Uwe Gieler,
Lucia Tomas-Aragones,
Géraldine Titeca,
Lars Lien
and
Mir-Saeed Shayegan Salek
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The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making. (2016)
R Donelan,
Stuart Walker
and
Mir-Saeed Shayegan Salek
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Patient-centered research and practice in the era of genomics: a novel approach. (2016)
Mir-Saeed Shayegan Salek,
Esther Oliva
and
Tatyana Ionova
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Appropriate and inappropriate influences on outpatient discharge decision making in dermatology : a prospective qualitative study. (2015)
N A Harun,
A Y Finlay,
M S Salek
and
V Piguet
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A practical approach to communicating benefit-risk decisions of medicines to stakeholders. (2015)
J Leong,
S Walker
and
Mir-Saeed Shayegan Salek
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The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. (2015)
Florence Dalgard,
Uwe Gieler,
Lucia Tomas-Aragones,
Lars Lien,
Francoise Poot,
Gregor B.E. Jemec,
Laurent Misery,
Csanád Szabó,
D Linder,
Francesca Sampogna,
A W M Evers,
Jon Anders Halvorsen,
Flora Balieva,
Jacek C. Szepietowski,
Dmitry Romanov,
SE Marron,
Ilknur K. Altunay,
Andrew Y. Finlay,
Mir-Saeed Shayegan Salek
and
Joerg Kupfer
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The development and validation of a disease-specific quality of life measure in hyperhidrosis : the Hyperhidrosis Quality of Life Index (HidroQOL©). (2015)
P Kamudoni,
B Mueller
and
M S Salek
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The impact of patients' chronic disease on family quality of life : an experience from 26 specialties. (2013)
Catherine Jane Golics,
Mohammad Khurshid Azam Basra,
M Sam Salek
and
Andrew Yule Finlay
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