Results 71 to 80 of about 26,646 (226)

Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs

BMC Pharmacology and Toxicology, 2017
Background The extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale.
Muhammad M. Hammami, Sophia J. S. De Padua, Rajaa Hussein, Eman Al Gaai, Nesrine A. Khodr, Reem Al-Swayeh, Syed N. Alvi, Nada Binhashim   +7 more
doaj   +1 more source

Capability Development in the European Medicines Regulatory Network—A European Learning Needs Analysis and Survey Study

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1288-1297, May 2026.
The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision‐making.
Naomi Beard, Marko J. Kallio, Luca Kosec, Ulrika Espefält Westin, on behalf of the IncreaseNET consortium   +4 more
wiley   +1 more source

Maternal‐to‐Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1223-1234, May 2026.
This review evaluates the available pharmacokinetic data on the plasma‐to‐breastmilk transfer of first‐ and second‐line T2DM drugs against available clinical guideline recommendations. A list of drug therapies for treating T2DM was generated from national and international clinical guidelines.
Katherine Richardson, Joshua Kiptoo, Beatrice Mpora Odongkara, Francis Williams Ojara, Catriona Waitt   +4 more
wiley   +1 more source

A Validated Reversed-Phase HPLC Method for the Determination of Atorvastatin Calcium in Tablets [PDF]

, 2014
A Reversed-Phase Liquid Chromatographic (RP-LC) assay method was developed for the quantitative determination of atorvastatin calcium in the presence of its degradation products.
Ferello, L., Repetto, M. F., Segall, Adriana Ines, Simionato, Laura Daniela, Stamer. S., Zubata, P. D.   +5 more
core  

A pharmacokinetic comparison of three pharmaceutical formulations of nimesulide in healthy volunteers [PDF]

, 2005
Background/Aim. Switching the patient from one pharmaceutical formulation of the same drug to another, may lead to therapeutic inadequancy in some cases. To minimize the risk, careful pharmacokinetic studies are desired in the pre-registration period and
Jovanović Dušan, Kilibarda Vesna, Potrebić Olivera, Todorović Veljko   +3 more
core   +1 more source

Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects

BMC Medical Research Methodology
Background This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.
Turki A. Althunian, Bader R. Alzenaidy, Raseel A. Alroba, Ohoud A. Almadani, Fahad A. Alqahtani, Albatool A. Binajlan, Amal I. Almousa, Deema K. Alamr, Malak S. Al-Mofada, Nora Y. Alsaqer, Hessa A. Alarfaj, Abdulmohsen A. Bahlewa, Mohammed A. Alharbi, Ali M. Alhomaidan, Abdulaziz A. Alsuwyeh, Abdulmohsen A. Alsaleh   +15 more
doaj   +1 more source

Ayurvedic herbal formulations Haridra Khanda and Manjisthadi Kwath (brihat) in the management of allergic rhinitis: A pharmacological study

Heliyon
This study aims to pharmacologically validate Haridra Khanda (HK) and Manjishthadi Kwatham (brihat) (MMK) in allergy management using invivo and invitro studies to rationalize the prescription of these two ayurvedic polyherbal drug formulations, which ...
Rudranil Bhowmik, Md Adil Shaharyar, Mahibub Mahamadsa Kanakal, Arnab Sarkar, Syeda Ayesha Farhana, Shalam M. Hussain, Abdullah Khan, Pallab Mandal, S. Roshan, Achintya Mitra, Sanmoy Karmakar   +10 more
doaj   +1 more source

Advancing Pharmacometrics in Africa: Insights and Perspectives From the 2025 Pharmacometrics Africa Conference

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1216-1222, May 2026.
Pharmacometrics (PMX) in Africa has transitioned from foundational capacity‐building to job creation, scientific leadership, regulatory influence, and health innovation. To accelerate this progress, the 2025 Pharmacometrics Africa Conference (PMXAC‐2025) convened key stakeholders to consolidate the continental PMX community, review progress in local ...
Babatunde Ayodeji Adeagbo, Innocent Gerald Asiimwe, Linda Chaba, Aida N. Kawuma, Francis Williams Ojara, Ochuko Maureen Orherhe, Simon Peter Asiimwe, Veshni Pillay‐Fuentes Lorente, Sharon Sawe, Cassius M. Phogole, Catriona Waitt, Samer Mouksassi, Goonaseelan (Colin) Pillai   +12 more
wiley   +1 more source

An encounter between metal ions and natural products: natural products-coordinated metal ions for the diagnosis and treatment of tumors

Journal of Nanobiotechnology
Natural products-coordinated metal ions to form the nanomedicines are in the spotlight for cancer therapy. Some natural products could be coordinated with metal ions forming nanomedicines via simple and green environmental self-assembly, which not only ...
Xinyue Liu, Suyi Liu, Xingyue Jin, Haifan Liu, Kunhui Sun, Xiongqin Wang, Meifang Li, Ping Wang, Yanxu Chang, Tiejie Wang, Bing Wang, Xie-an Yu   +11 more
doaj   +1 more source

A Comparative Pharmacokinetics Study of the Anti-Parkinsonian Drug Pramipexole

Scientia Pharmaceutica, 2016
The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 ...
Ratih S. I. Putri, Effi Setiawati, Syifa A. Aziswan, Fenny Ong, Raymond R. Tjandrawinata, Liana W. Susanto   +5 more
doaj   +1 more source