Results 111 to 120 of about 104,914 (293)

A Mathematical Approach to Comply with Ethical Constraints in Compassionate Use Treatments

, 2018
Patients who are seriously ill may ask doctors to treat them with unapproved medication, about which not much is known, or else with known medication in a high dosage. Apart from strict legal constraints such cases may involve difficult ethical questions
Bruss, F. Thomas
core  

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]

, 2005
Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core   +1 more source

A phase 1 evaluation of inhaled oxytocin: Physiologically‐based pharmacokinetic model informed dosing of a novel heat‐stable oxytocin delivery system

British Journal of Clinical Pharmacology, EarlyView.
Aim To develop and validate a physiologically‐based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non‐pregnant female participants.
Pete Lambert, Carl M. J. Kirkpatrick, Rory Marriott, Siladitya Ray Chaudhuri, David Polidori, Bart Remmerie, Michelle P. McIntosh   +6 more
wiley   +1 more source

Contraindicated drug–drug interactions and associated adverse drug reactions in an observational cohort study of 4543 paediatric hospitalized patients

British Journal of Clinical Pharmacology, EarlyView.
Abstract Background and Purpose Drug–drug interactions (DDIs) are associated with an increased risk of adverse drug reactions (ADRs). Hospitalized children are particularly vulnerable to DDIs and ADRs due to polypharmacy, frequent use of unlicensed or off‐label medications, and dosing regimens often extrapolated from adult data.
Emilie Laval, Sylvain Goutelle, Inesse Boussaha, Xavier Dode, Yanis Mimouni, Kim An Nguyen, Behrouz Kassai   +6 more
wiley   +1 more source

Study of pharmacokinetic parameters and safety of the drug Duonica® in comparison with the original combination of doxylamine and pyridoxine under fed conditions

Фармакокинетика и Фармакодинамика
Aim. A comparative study of the pharmacokinetics and safety of the investigational drug Duonica®, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia) and the reference drug Diclectin®, delayed-release tablets, 10 mg + 10 mg ...
I. E. Shohin, S. M. Noskov, A. A. Globenko, N. S. Bagaeva, K. K. Karnakova, O. M. Parulya, L. N. Lutskova, A. V. Kapashin, M. A. Pasko   +8 more
doaj   +1 more source

Facing the Trial of Internationalizing Clinical Trials to Developing Countries: Some Evidence from Mexico [PDF]

In pursuit of innovation, developing countries play an increasingly relevant role for multinational pharmaceutical firms. Driven partly by cost considerations but also by some host country-specific scientific and technological factors, global drug ...
Santiago-Rodriguez, Fernando
core  

Repeated intradermal lipopolysaccharide challenge responses in healthy volunteers: Implications for clinical pharmacology studies

British Journal of Clinical Pharmacology, EarlyView.
Aim Intradermal application of lipopolysaccharide (LPS), a Toll‐like receptor 4 agonist, induces a local inflammatory response and is used as a human challenge model to evaluate the pharmacodynamics of investigational medicinal products. While currently applied in a single, parallel‐group setting, alternative within‐subject designs involving repeated ...
Alexandra A. J. Sillé, Juliette A. van den Noort, Iva Lelios, Diana R. Pereira, Marzia A. Scelsi, Erica S. Klaassen, Philipp Schoenenberger, Naomi B. Klarenbeek, Pierre‐Eric Juif, Pascal Espie, Manon A. A. Jansen, Matthijs Moerland, Richard W. D. Welford   +12 more
wiley   +1 more source

Organoid models: Regulations and prospects for the development of investigational new drugs

Chinese Medical Journal
. Over the past decade, research associated with organoids has entered a golden era, marking a significant shift in the biomedical landscape. Organoids have been widely applied in the industrial sector and have gained recognition from regulatory ...
Huachao Li, Yin Pan, Zhibao Zheng, Renzhi Lin, Yue Pan, Lizhong Lin, Mingming Quan, Hongsheng Lu, Zhe Hu, Mingbin Zheng, Yihua Chen, Yuzhu Zhang, Sihan Zhou, Xiuyuan Hao   +13 more
doaj   +1 more source

Transforming Brain Health With Neurotechnology Convergence (Part II): Intelligent Neurointervention Systems for Neurological Disorders

Brain Health, EarlyView.
ABSTRACT Neurological disorders represent a critical domain within global health, necessitating advanced interventions to address complex pathologies such as tumors, functional disorders, and cerebrovascular diseases. Despite the proven benefits of early intervention, current treatment paradigms face significant challenges: (1) limited precision in ...
Qing Ye, Fei Peng, Chao Pan, Ping Zhang, Xuewei Xie, Zixiao Li, Yingxin Tang, Danyang Chen, Yuanwei Li, Jiawen Wu, Zao Han, Qing Dai, Quansheng Gu, Jizong Zhao, Zhouping Tang   +14 more
wiley   +1 more source

Strain Release of 1‐Azabicyclo[1.1.0]butanes as a Gateway to Highly Functionalized Azetidines: New Strategies and Structural Motifs

Chemistry – A European Journal, EarlyView.
Over the past decade, the interest in azetidines has continuously risen, by virtue of their highly appealing pharmaceutical properties. Monocyclic, spirocyclic, and bridged azetidines can be accessed by leveraging 1‐azabicyclo[1.1.0]butanes as precursors.
Yuri Gelato, Philipp Natho, Marco Colella, Renzo Luisi   +3 more
wiley   +1 more source