Results 161 to 170 of about 2,705,771 (305)

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

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

British Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang, Daniala L. Weir, Safana Thevasahayam, Vera H. M. Deneer, Arno Siebes, Helga Gardarsdottir   +5 more
wiley   +1 more source

Health-related quality of life in benign thyroid diseases assessed by ThyPRO. [PDF]

Endocr Connect
Sawicka-Gutaj N, Derwich-Rudowicz A, Bromińska B, Maciejewska J, Nijakowski K, Kozłowska P, Adamczak O, Rytelewski Z, Kyriacou A, Ruchała M.   +9 more
europepmc   +1 more source

Lithium‐related adverse drug reactions in children: A case–control study comparing lithium to second‐generation antipsychotics in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to improve the understanding of lithium's safety profile by analysing the frequency and distribution of reported adverse drug reactions (ADRs) compared to second‐generation antipsychotics (SGAs). Methods Individual case safety reports from VigiBase (1968–October 2023) involving individuals older than 2 years, with lithium or SGAs ...
Lisa T. Ringeling, Ravish N. Gangapersad, Lillian Lieuw, Patrick C. Souverein, Eibert R. Heerdink, Pilar Garcia‐Gomez, Manon H. J. Hillegers, Birgit C. P. Koch, Bram Dierckx   +8 more
wiley   +1 more source

Vitamin D and gut microbiota in thyroid diseases: mechanisms and therapeutic potential. [PDF]

Front Immunol
Jiao M, Zhai X, Jia Z, Gong B, Shen R, Liu Y, Zhang D, Shan Z, Wang C.   +8 more
europepmc   +1 more source

Prevalences of Other Non-Thyroid Autoimmune Diseases and Factor Associated with Their Presence in Ocular Myasthenia Gravis [PDF]

Thanathon Anutraungkool,1 Tanyatuth Padungkiatsagul,1 Panitha Jindahra,2 Kavin Vanikieti1 1Department of Ophthalmology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; 2Department of Medicine, Faculty of Medicine ...
Anutraungkool T, Vanikieti K, Jindahra P, Padungkiatsagul T   +3 more
core  

Pharmacokinetics and safety of a modified‐release psilocybin formulation: A SAD Phase I trial in normal‐weight and overweight/obese participants

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to evaluate the safety, tolerability and pharmacokinetics of a novel oral modified‐release psilocybin formulation (REL‐P11) in normal‐weight and overweight/obese healthy adults and to assess its suitability for controlled, subperceptual exposure, in light of emerging evidence supporting serotonergic modulation in metabolic ...
Anna Signor, Stefano Comai, Gianfranco Pasut, Franco Folli, Marco Gentilucci, Negar Gharavi, Sofia Raitsin, Thuy Van Nguyen, Marco Pappagallo, Andrea Mattarei, Paolo L. Manfredi, Sara De Martin   +11 more
wiley   +1 more source

Serum 25-hydroxyvitamin D levels are associated with thyroid diseases: A systematic review and meta-analysis. [PDF]

Medicine (Baltimore)
Luo W, Chen K, Li X.
europepmc   +1 more source

Prevalence of pregnancy and birth outcomes following biologic exposure in immune‐mediated inflammatory diseases: A population‐based study

British Journal of Clinical Pharmacology, EarlyView.
Aims Almost 5% of pregnancies are affected by immune‐mediated inflammatory diseases (IMIDs). As treatments become available, understanding their use during pregnancy is important. We aimed to describe maternal, pregnancy and infant outcomes among IMID pregnancies exposed to biologic therapies. Methods Using the Merative™ MarketScan® Commercial Database,
Leah K. Flatman, Lisiane F. Leal, Gabra Nohmie, Anick Bérard   +3 more
wiley   +1 more source

Causal effects of antihypertensive drugs on thyroid diseases: A trans-ancestry drug-target Mendelian randomization study. [PDF]

Medicine (Baltimore)
Wang XH, Zhang YY, Wan Q.
europepmc   +1 more source