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The EMA defines acceptability as "the overall ability and willingness of the patient to use, and their caregiver to administer, the medicine as intended" [1]. This paper seeks to outline issues of acceptability in relation to injectable therapy, namely intravenous (IV), intramuscular (IM) and subcutaneous (SC) administration routes, and to lay a foundation to identify a minimum set of data that would satisfy Regulatory Authorities when discussing the acceptability of an injectable product. In addition, it will alert drug product developers to other factors that might contribute to good practice, alternative administration strategies and overall adherence to achieve successful treatment. Whilst the term 'parenteral' means "outside the intestine" [2,3] and so potentially covers a range of administration routes including intranasal and percutaneous administration, this review focuses on IV, IM and SC administration by injection. The use of indwelling canulae or catheters to reduce venepuncture and facilitate prolonged treatment is common and may impact acceptability [4]. This may be influenced by information provided by the manufacturer but is not always in their direct control. Other injectable products suitable for routes such as intradermal, intra-articular, intraosseous and intrathecal, share the requirement to be acceptable but are not specifically covered in this paper [2,5].
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http://dx.doi.org/10.1016/j.ejpb.2023.04.010 | DOI Listing |
Angiogenesis
December 2024
Service de Génétique et centre de reference de la maladie de Rendu-Osler, Hôpital Femme-Mère-Enfants, Hospices Civils de Lyon, Bron, France.
Epistaxis greatly affects patients with hereditary hemorrhagic telangiectasia (HHT). Although few systemic treatment exist, nintedanib, is a good candidate thanks to its anti-angiogenic activity. Our main objective was to evaluate the efficacy of oral nintedanib on epistaxis duration in HHT patients with moderate to severe epistaxis.
View Article and Find Full Text PDFRadiology
December 2024
From the Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom (B.J.P., M.A.N., C.W.H., A.J.S., P.E.T.); Newcastle Magnetic Resonance Centre, Health Innovation Neighbourhood, Newcastle University, Newcastle upon Tyne NE4 5PL, United Kingdom (B.J.P., M.A.N., C.W.H., P.E.T.); Pulmonary, Lung and Respiratory Imaging Sheffield, Section of Medical Imaging and Technologies, Division of Clinical Medicine, School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom (A.M.M., J.M.W.); Department of Respiratory Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom (I.F.); Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom (R.A.L.); Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom (H.F.F., J.N.S.M.); and Insigneo Institute, University of Sheffield, Sheffield, United Kingdom (J.M.W.).
Background Pulmonary function tests are central to diagnosis and monitoring of respiratory diseases but do not provide information on regional lung function heterogeneity. Fluorine 19 (F) MRI of inhaled perfluoropropane permits quantitative and spatially localized assessment of pulmonary ventilation properties without tracer gas hyperpolarization. Purpose To assess regional lung ventilation properties using F MRI of inhaled perfluoropropane in participants with asthma, participants with chronic obstructive pulmonary disease (COPD), and healthy participants, including quantitative evaluation of bronchodilator response in participants with respiratory disease.
View Article and Find Full Text PDFMol Ther Methods Clin Dev
December 2024
Preclinical Safety (PCS), Novartis Biomedical Research, Cambridge, MA, USA.
Administration of AAV-based gene therapies into the intra-cerebrospinal fluid (CSF) compartments via routes such as lumbar puncture (LP) has been implemented as an alternative to intravenous dosing to target the CNS regions. This route enables lower doses, decreases systemic toxicity, and circumvents intravascular pre-existing anti-AAV antibodies. In this study, AAV9-GFP vectors were administered via LP to juvenile cynomolgus macaques with and without pre-existing serum anti-AAV9 antibodies at a 5.
View Article and Find Full Text PDFCurr Res Microb Sci
November 2024
Department of Microbiology, Faculty of Biotechnology and Biomolecular Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
The threat of influenza A virus (IAV) remains an annual health concern, as almost 500,000 people die each year due to the seasonal flu. Current flu vaccines are highly dependent on embryonated chicken eggs for production, which is time consuming and costly. These vaccines only confer moderate protections in elderly people, and they lack cross-protectivity; thereby requiring annual reformulation to ensure effectiveness against contemporary circulating strains.
View Article and Find Full Text PDFDrug Des Devel Ther
December 2024
Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, People's Republic of China.
Purpose: Intrathecal morphine is increasingly used for pain management in laparoscopic colorectal surgery. While ropivacaine shows advantages of reduced cardiotoxicity and faster motor recovery compared to bupivacaine, the impact of intrathecal morphine-ropivacaine combination on postoperative recovery quality remains unclear. This study aimed to evaluate this combination's effect on recovery outcomes after laparoscopic colorectal surgery.
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