Results 31 to 40 of about 16,124 (183)

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Translational development of crisugabalin for neuropathic pain

British Journal of Clinical Pharmacology, EarlyView.
Abstract Crisugabalin (HSK16149) is a next‐generation α2δ ligand developed to preserve the mechanistic rationale of gabapentinoids while refining target engagement and exposure‐related tolerability constraints. We performed a translational review of molecular/structural studies, in vivo pharmacology and behavioural safety assessments, phase I clinical ...
Rafael Batista João, Jilly Octoria Tagore Chan, Luísa Mendes Araújo, André Batista João, Raquel Mattos Filgueiras, Paulo César Ragazzo   +5 more
wiley   +1 more source

Bioequivalence centres in Africa: current state and opportunities for growth

Journal of Pharmaceutical Policy and Practice
Bioequivalence studies are required for generic medicines to meet the same quality, safety, and efficacy standards as innovator products before receiving marketing authorisation. These studies compare the in vivo performance of a generic medicine to that
Bakani Mark Ncube, Sarah Muthuri, Olawale Ajose, Loice Kikwai   +3 more
doaj   +1 more source

Virtual Twin Approach Using Physiologically Based Pharmacokinetic Modeling to Support Precision Dosing of Valproic Acid in Geriatric Patients

Clinical Pharmacology &Therapeutics, EarlyView.
Personalized dosing is particularly important for drugs with narrow therapeutic indices in geriatric patients, who exhibit substantial physiological variability and limited pharmacokinetic (PK) evidence to guide individualized dose selection. Valproic acid (VPA) is an effective treatment option for bipolar disorder in older adults, yet dosing largely ...
Yoo Jin Jang, Dong‐Gyu Heo, Eunjin Hong   +2 more
wiley   +1 more source

Advances in brain-targeted delivery strategies and natural product-mediated enhancement of blood–brain barrier permeability

Journal of Nanobiotechnology
The blood–brain barrier (BBB) represents a formidable challenge in the treatment of neurological disorders, as it restricts the passage of most therapeutic agents into the central nervous system (CNS).
Suyi Liu, Xingyue Jin, Yuanyuan Ge, Junlin Dong, Xinyue Liu, Xiao Pei, Ping Wang, Bing Wang, Yanxu Chang, Xie-an Yu   +9 more
doaj   +1 more source

Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl

Фармакокинетика и Фармакодинамика, 2023
Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 ...
A. L. Khokhlov, A. A. Khokhlov, A. E. Miroshnikov, O. V. Lebedeva, D. Yu. Grebenkin   +4 more
doaj   +1 more source

Physiologically Based Pharmacokinetic Modeling to Assess Transporter‐Mediated Drug–Drug Interactions in Support of Labeling Recommendations for Zavegepant Nasal Spray

Clinical Pharmacology &Therapeutics, EarlyView.
Zavegepant nasal spray, a calcitonin gene‐related peptide receptor antagonist indicated for acute treatment of migraine with or without aura in adults, is a substrate for organic anion transporting polypeptide 1B3 (OATP1B3), Na+/taurocholate cotransporting polypeptide (NTCP), P‐glycoprotein (P‐gp), and cytochrome P450 3A4 (CYP3A4).
Alice Ke, Ernesto Callegari, Manthena V.S. Varma, Mayur K Ladumor, Chieko Muto, Richard J. Bertz, Hannah M. Jones, Vaishali Sahasrabudhe, Jing Liu   +8 more
wiley   +1 more source

Recent advances in self-targeting natural product-based nanomedicines

Journal of Nanobiotechnology
Natural products, recognized for their potential in disease prevention and treatment, have been integrated with advanced nano-delivery systems to create natural product-based nanomedicines, offering innovative approaches for various diseases.
Haifan Liu, Xingyue Jin, Suyi Liu, Xinyue Liu, Xiao Pei, Kunhui Sun, Meifang Li, Ping Wang, Yanxu Chang, Tiejie Wang, Bing Wang, Xie-an Yu   +11 more
doaj   +1 more source

How to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions

Clinical Pharmacology &Therapeutics, EarlyView.
Healthy volunteers (HVs) are essential for phase I trials, yet their recruitment and screening remain resource‐intensive and ethically complex. High screening failure (SF) rates highlight the need to evaluate and understand all aspects of the enrolment processes. We analyzed SF patterns in a large German HV cohort and explored participants' motivations,
Evelyn Krohmer, Manuela König, Cathrin J. Vogt, Marina Streckebein, Sybille Baumann, Max Blumenstock, Ruwen Böhm, Fabian Müller, Nadja Struß, Viktoria S. Wurmbach, Antje Blank   +10 more
wiley   +1 more source

Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians

, 2017
5 páginasA study with the aim to compare the bioavailability of two 400 mg imatinib formulations, test product Zeite® from Laboratorio Synthesis S.A.S., Colombia, and reference product Glivec® from Novartis Pharma, and determine if bioequivalence can be ...
Vargas M., Villarraga E.
core   +1 more source