Results 51 to 60 of about 25,741 (229)

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Discussion and Research on Some Issues in Helium Pressure Test Technology for Dummy Sealed Source

Journal of Isotopes
In order to solve some problems existing in the helium pressure leak detection technology of the pseudo-sealed source and clarify the calculation formula and test method, the paper deduces the helium pressure leak detection formula of the pseudo-sealed ...
Zhuo XU, Chenzhong SHI, Yan MA, Yun ZHANG   +3 more
doaj   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Brief Analysis of the Validation of Analytical Methods for Radiopharmaceuticals

Journal of Isotopes
Method validation is an important step to ensure the accuracy and reliability of analytical method，and is the basis for ensuring the controllable quality of drugs.
Mengyi CHEN, Weihua CHENG, Hongyu LI
doaj   +1 more source

Fueling Tomorrow: Scenario Planning for the Future of Gas Stations

Business Strategy and the Environment, EarlyView.
ABSTRACT Transport electrification is reshaping the service infrastructures that mediate everyday mobility, yet most electrification scenario studies remain macrolevel and offer limited insight into how incumbent forecourt (gas‐station) networks can adapt under deep uncertainty.
Joao Gabriel Rosa, Fabiano Armellini, Jean‐Marc Robert   +2 more
wiley   +1 more source

Data Classification Methodology: The Way Forward to Data-Enabled Healthcare in Egypt [PDF]

Global Journal on Quality and Safety in Healthcare
A robust data management system is crucial for healthcare entities to get value from the exponential volume of generated and stored data. Given the impact of data on the decision-making process at the individual, organizational, and institutional levels,
Gihan Hamdy Elsisi, Yousra Hamed
doaj   +1 more source

Repurposing Registries: Completeness of Real‐World Data for Regulatory and HTA Purposes in Three Cancer‐Focused Registries

Clinical Pharmacology &Therapeutics, EarlyView.
Despite developments in supporting the identification and selection of fit‐for‐purpose registries, a translational gap remains between the original purposes of clinically focused registries and their current and future expected use in policymaking. This study aimed to assess the extent to which cancer‐focused registries collect essential data elements ...
Manon C. Wilpshaar, Doranne Hilarius, Luisa Prada, Ansgar Weltermann, Christine Leopold   +4 more
wiley   +1 more source

Navigating the Prescription Drug Information System

Clinical Pharmacology &Therapeutics, EarlyView.
Information on new prescription drugs is increasingly complex and fragmented, posing challenges for healthcare professionals, patients, and payers. Clinicians require concise, actionable guidance to support prescribing decisions, while patients seek to balance benefits and harms when making decisions aligned with their treatment goals.
Irina V. Wang, Courtney Davis, Robin Forrest, Avi Cherla, Maximilian Siebert, Janice Cowden, Sophia Walker, Tamar Krishnamurti, Florence T. Bourgeois, Steven Woloshin, Anita K. Wagner, Huseyin Naci   +11 more
wiley   +1 more source

The Multiple Criteria Qualitative Value‐Based Pricing Framework “MARIE” for Novel Cell and Gene Therapy

Clinical Pharmacology &Therapeutics, EarlyView.
When setting the price of cell and gene therapies in Japan, the factors considered include the manufacturing and operating costs of the new drug or a comparator, leading to discrepancies between price and values, in particular those specific to cell and gene therapies.
Akina Takami, Ataru Igarashi
wiley   +1 more source

Organizational structure and funding of health technology assessment agencies around the world

Фармакоэкономика, 2019
Aim: analyze the structure and funding of health technology assessment (HTA) agencies abroad.Materials and methods. Here, we review the organizational structure and funding of HTA agencies in Europe (Austria, Belgium, Germany, Ireland, the Netherlands ...
G. R. Khachatryan, V. V. Omelyanovskiy, L. S. Melnikova, S. S. Ratushnyak   +3 more
doaj   +1 more source