Results 121 to 130 of about 4,391,067 (296)

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

HIV drug resistance in persons who inject drugs enrolled in an HIV prevention trial in Indonesia, Ukraine, and Vietnam: HPTN 074.

PLoS ONE, 2019
BackgroundPersons who inject drugs (PWID) have high HIV incidence and prevalence, and may have limited access to antiretroviral therapy (ART) in some settings. We evaluated HIV drug resistance in PWID in a randomized clinical trial (HPTN 074).
Philip J Palumbo, Yinfeng Zhang, Jessica M Fogel, Xu Guo, William Clarke, Autumn Breaud, Paul Richardson, Estelle Piwowar-Manning, Stephen Hart, Erica L Hamilton, Ngo T K Hoa, Mariya Liulchuk, Latifah Anandari, Tran Viet Ha, Kostyantyn Dumchev, Zubairi Djoerban, Irving Hoffman, Brett Hanscom, William C Miller, Susan H Eshleman   +19 more
doaj   +1 more source

Pharmacogenomics of dolutegravir: A scoping review of evidence, gaps and clinical implications

British Journal of Clinical Pharmacology, EarlyView.
Dolutegravir underpins modern first‐ and second‐line HIV treatment regimens; however, interindividual variability in its disposition and tolerability presents challenges for optimal use. This scoping review mapped current evidence on the pharmacogenomics of dolutegravir, focusing on pharmacokinetics and pharmacodynamics, and methodological limitations ...
Ronald Kiguba, Mishael Ssesanga, Munir Pirmohamed   +2 more
wiley   +1 more source

Predicting adherence to antiretroviral therapy and retention to HIV care : effects of baseline biopsychosocial status and neuropsychological functioning [PDF]

, 2011
These drugs have demonstrated efficacy in improving immune function and reducing HIV-related morbidity and mortality, and while a cure is not available, patients on treatment may live longer, healthier lives.
Mark, Daniella
core   +1 more source

Rapid onset and offset of the interaction between rifampicin and long‐acting cabotegravir/rilpivirine: A pharmacokinetic case report

British Journal of Clinical Pharmacology, EarlyView.
Long‐acting intramuscular cabotegravir/rilpivirine (LA CAB/RPV) is contraindicated with rifampicin because of the risk of markedly reduced antiretroviral exposure, although clinical pharmacokinetic data for this interaction are lacking. We describe a 49‐year‐old man with virologically suppressed HIV‐1 infection receiving LA CAB/RPV every 8 weeks who ...
Emilie M. Gieling, Lisanne A. H. Bevers, Wouter L. Smit, Rosa H. Elias, Annelies Verbon, David M. Burger, Berend J. van Welzen   +6 more
wiley   +1 more source

Lenacapavir initiation with concomitant primidone: A case report with therapeutic drug monitoring

British Journal of Clinical Pharmacology, EarlyView.
Lenacapavir (LEN), a first‐in‐class capsid inhibitor, has unique pharmacokinetics that enable twice‐yearly dosing. LEN is not extensively metabolized, although it is a substrate of CYP3A4, which introduces drug–drug interactions concerns. As adoption and implementation of LEN for treatment and prevention increase, additional guidance on concomitant ...
Aaron S. Devanathan, Thomas Glowa, Emily M. Thompson, Amanda J. Saylor, Thomas D. Nolin, Sharon A. Riddler, Ken S. Ho   +6 more
wiley   +1 more source

Isolating T‐Cell Potent Lentiviral Vector Subpopulations through Rational Design of Nanofiber Anion‐Exchange Adsorbents

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Generation of CAR‐T cell therapies relies predominantly on lentiviral vectors (LVs). As in vivo CAR‐T trials progress, demand for larger quantities of higher‐potency LV is expected. However, primary capture by anion‐exchange chromatography (AIEX) remains a major manufacturing bottleneck from use of adsorbents not tailored to LVs, leading to ...
George Pamenter, Gyorgy Ovari, Anurag Kulkarni, Thomas Williams‐Fegredo, Carol Knevelman, Kyriacos Mitrophanous, Lee Davies, Farzad Foroutan, Matthew Townsend, Stephen Goldrick, Daniel G. Bracewell   +10 more
wiley   +1 more source

Drug resistance from preferred antiretroviral regimens for HIV infection in South Africa: A modeling study.

PLoS ONE, 2019
BACKGROUND:Tenofovir-containing regimens comprise the preferred first-line antiretroviral therapy (ART) in many countries including South Africa, where utilization of second-line regimens is limited.
Ume L Abbas, Robert L Glaubius, Yajun Ding, Gregory Hood   +3 more
doaj   +1 more source

Bridging the translational gap in clinical nanomedicine: From rational design to clinical reality

BMEMat, EarlyView.
Nanotechnology offers a multi‐faceted approach to modern healthcare, encompassing high‐sensitivity diagnostic imaging, innovative vaccine delivery, and targeted therapeutics. This review explores how these nanomedicine applications address critical challenges in cancer recurrence and the treatment of neurologic and respiratory diseases to combat rising
Ahmed H. Ghonaim, Marwa Ahmed El‐Naka, Wedad M. Nageeb, Atta Ullah Khan, Noura M. Seleem, Aliaa Abdelghafar, Doaa Zamel, Yang Liu, Qigai He, Wentao Li   +9 more
wiley   +1 more source

Population genetic approaches to estimating the size of the HIV reservoir

Journal of Virus Eradication, 2015
J. Hattori, V. Boltz, W. Shao, M. Kearney, F. Maldarelli   +4 more
doaj   +1 more source