Results 41 to 50 of about 6,056 (173)

Post-Marketing Surveillance of a generic Oxaliplatin (AlvoxalⓇ) in Iranian Patients with Cancer

Current Therapeutic Research, 2022
: Background: CRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic ...
Farhad Shahi, Mojtaba Gorji, Assistant Professor of Pediatric Oncology, Mehrdad Payandeh, Assistant Professor of Hematology & Oncology, Hamid Rezvani, Associate Professor of Hematology & Oncology, Mohammad Vaezi, Associate Professor of Hematology & Oncology, Sharareh Seifi, Assistant Professor of Hematology & Oncology, Alireza Baari, Post doctoral fellowship, Reza Khalili-Dizaji, Post doctoral fellowship, Seyed Mehdi Hashemi, Associate Professor of Hematology & Oncology, Saeid Salimi, post doctoral fellowship, Hosein Kamranzadeh, Associate Professor of Hematology & Oncology, Babak Shazad, Post doctoral fellowship, Sina Salari, Associate Professor of Hematology & Oncology, Davoud Oulad Dameshghi, Assistant Professor of Hematology & Oncology, Mehdi Sarkheil, Post doctoral fellowship, Mehrzad Mirzania, Associate Professor of Hematology & Oncology, Nassim Anjidani, Pharm. D.   +16 more
doaj   +1 more source

An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice [PDF]

, 2012
Background: Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and
Abernethy, Amy Pickar, Currow, David Christopher, Doogue, Matthew, Rowett, Debra Sharon, To, Timothy H M   +4 more
core   +1 more source

Actions to mitigate ocular adverse events related to hair styling cosmetics in Brazil: a descriptive and correlational study (2022-2024) [PDF]

Epidemiologia e Serviços de Saúde
Objective To describe health surveillance actions implemented by the Brazilian Health Regulatory Agency (ANVISA) to mitigate cases of ocular adverse events related to hair styling creams in Brazil and verify correlation between reported cases and these ...
Daniel Marques Mota, Leonardo Oliveira Leitão, Ronald Santos Silva, Cássia de Fátima Rangel Fernandes, Marcus Tolentino Silva   +4 more
doaj   +1 more source

Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis

AAPS Open, 2017
Background While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in which patients experience ...
David A. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, Paul Wicks, James Weatherall   +6 more
doaj   +1 more source

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements [PDF]

, 2018
The United States Food and Drug Administration (FDA) has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs
Naci, Huseyin, Ross, Joseph S., Wallach, Joshua D.   +2 more
core   +1 more source

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

Clinics, 2014
OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify ...
Fabiana Rossi Varallo, Helaine Carneiro Capucho, Cleópatra da Silva Planeta, Patrícia de Carvalho Mastroianni   +3 more
doaj   +1 more source

Squamous-cell carcinoma of the tongue following therapy of rheumatoid arthritis with abatacept [PDF]

, 2014
A patient affected by rheumatoid arthritis developed a squamous-cell carcinoma probably due to abatacept, according to Naranjo algorithm. The case describes this adverse reaction for the first time and highlights the need for additional studies to ...
Deidda, Arianna, Garau, Donatella, Longu, Maria Giovanna, Moretti, Grazia Maria Rita, Moretti, Mario Domenico Luigi, Pisanu, Claudia, Sanna, Maria Elena, Stochino, Maria Eminia   +7 more
core   +1 more source

Reshaping study design for faster extrapolation‐based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN–NASPGHAN position paper

Journal of Pediatric Gastroenterology and Nutrition, EarlyView.
Abstract Children with inflammatory bowel diseases (IBD) have limited access to the available advanced therapies, given the lengthy gap between adult and pediatric approval. We aimed to review key hurdles for pediatric trials and recommend practical solutions.
Dan Turner, Amit Assa, Mikkel Malham, Shira Yuval Bar‐Asher, Carla Rayan, Jeffrey S. Hyams, Holm H. Uhlig, Brad Pasternak, David C. Wilson, Hilary K. Michel, Lissy de Ridder, Eric Zuckerman, Marina Aloi, Peter Szitanyi, Marla C. Dubinsky, Anne M. Griffiths, Roberto Saldana, Javier Martín‐de‐Carpi, Eytan Wine, Richard K. Russell, Jeremy Adler, Joseph Picoraro   +21 more
wiley   +1 more source

Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope for the treatment of adult patients with growth hormone deficiency

Therapeutic Advances in Endocrinology and Metabolism, 2012
Objective : To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope ® ) for the treatment of adult patients with growth hormone deficiency (GHD).
Paolo Beck-Peccoz, Francesco Minuto, Alfonso Leal-Cerro, Markus Zabransky, Günter Stalla   +4 more
doaj   +1 more source

Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study [PDF]

Diabetes & Metabolism Journal
Background To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM). Methods This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park   +5 more
doaj   +1 more source