Results 71 to 80 of about 16,760 (259)

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

La ruota degli esposti dell’Ospedale Grande del Santo Spirito di Palermo [PDF]

Papireto
The study presents new acquisitions on the foundling wheel of the Ospedale Grande del Santo Spirito in Palermo and an unpublished sacristy washbasin characterised by the st. Bernardine monogram from the ancient church of the hospital. The history of the
Riccardo Prinzivalli
doaj   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Engineered interfaces of MoS2-heterojunctions for dye removal: Strategies and perspectives of electron–hole dynamics

Chemistry of Inorganic Materials
The remediation of persistent and toxic pollutants, including synthetic dyes from textile, leather, and printing industries, discharged into the aquatic bodies, demands the development of efficient photocatalysts.
Palliyalil Sirajudheen, Chettithodi Poovathumkuzhi Nabeena, Sivakumar Vigneshwaran   +2 more
doaj   +1 more source

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

Divesting the Orphanage Industry: Ending Australia’s participation in the business model of orphanage trafficking

, 2017
The purpose of this report is to: ➢ Provide a rationale for developing a holistic multi-tiered strategy to combatting Australia’s role in the orphanage trafficking business model; ➢ Ensure Australia’s response to orphanage trafficking is consistent with ...
van Doore, Kathryn, Nhep, Rebecca
core  

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

Biotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source

Food intake, Sanitary Practices and Nutritional Status of School-Aged Children (6-12years) Living in Orphanages in Lagos State, Nigeria

International Journal of Home Economics, Hospitality and Allied Research
This study examined the food intake, sanitary practices and nutritional status of School-aged children in three 3 orphanages in Lagos State. The study was guided by four research questions and one hypothesis.
Jummai S. Seriki-Mosadolorun, Ifeoma. A. Akeredolu, Tinu-Lano Maduagu, Victoria V. Nkan   +3 more
doaj   +1 more source