Results 71 to 80 of about 16,304 (256)

Friction and Wear Characterizations in Electrospun Nanofibrous Scaffolds for Cartilage Engineering

Nano Select, EarlyView.
Articular cartilage (AC)‐engineered electrospun scaffolds have experienced a surge in interest in publication in recent years. However, nanofiber frictional properties are poorly explored in the existing literature. We evaluated the effect of countersurface, speed, and hydrophilicity on nanofibers.
André Mathias Souza Plath, Mohammad Alinezhadfar, Stephen J. Ferguson   +2 more
wiley   +1 more source

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source

Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies

Drug Metabolism and Pharmacokinetics, 2019
The concept of biosimilar was established in the early 2000s in EU. Currently, the regulatory framework for biosimilar has also been established in the US, Japan, and other countries. As of 2018, biosimilars for infliximab, adalimumab, rituximab, trastuzumab, and bevacizumab have been approved.
Takashi Kuwabara, Akiko Ishii-Watabe
openaire   +3 more sources

Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape

Small, EarlyView.
This review presents a detailed overview of clinically approved nanoparticle therapeutics, classifying them by type and discussing their unique advantages in drug delivery. It highlights regulatory challenges across global markets and emphasizes the need for adaptive approval pathways.
Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora   +5 more
wiley   +1 more source

Biosimilars: Extrapolation for oncology

Critical Reviews in Oncology/Hematology, 2016
A biosimilar is a biologic that is highly similar to a licensed biologic (the reference product) in terms of purity, safety and efficacy. If the reference product is licensed to treat multiple therapeutic indications, extrapolation of indications, i.e., approval of a biosimilar for use in an indication held by the reference product but not directly ...
G. Curigliano, D. P. O'Connor, J. A. Rosenberg, I. Jacobs   +3 more
openaire   +4 more sources

Experimental and Computational Insights into the Structural Dynamics of the Fc Fragment of IgG1 Subtype from Biosimilar VEGF‐Trap

Small Structures, EarlyView.
The constant fragment (Fc) of the immunoglobulin G1 (IgG1) subtype is a widely used scaffold for designing advanced therapeutics. Herein, together with the integration of experimental and computational techniques, this study reveals the structural dynamics of the N‐glycan‐bound Fc fragment of IgG1 from VEGF‐Trap, providing a new insight into enhancing ...
Ebru Destan, Engin Turkut, Alper Aldeniz, Jungmin Kang, Takehiko Tosha, Makina Yabashi, Baris Yilmaz, Ahmet Can Timucin, Hiroaki Matsuura, Yoshiaki Kawano, Irfan Cinkaya, Hasan DeMirci   +11 more
wiley   +1 more source

Health technology assessment of biosimilars worldwide: a scoping review

Health Research Policy and Systems, 2020
Background Health technology assessment (HTA) should provide an assessment of a technology’s effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity,
Bruna de Oliveira Ascef, Ana Carolina de Freitas Lopes, Patrícia Coelho de Soárez   +2 more
doaj   +1 more source

Insulin Out‐of‐Pocket Spending Caps and Employer‐Sponsored Insurance: Changes in Out‐of‐Pocket and Total Costs for Insulin and Healthcare

Health Services Research, EarlyView.
ABSTRACT Objective To estimate the impact of state‐level insulin out‐of‐pocket caps on changes in out‐of‐pocket and total costs of insulin and healthcare for insulin users with employer‐sponsored insurance. Study Setting and Design We evaluated changes in costs using a quasi‐experimental (triple difference‐in‐differences; “DDD”) design to analyze multi‐
Khrysta A. Baig, Carrie E. Fry, Melinda B. Buntin, Alvin C. Powers, Stacie B. Dusetzina   +4 more
wiley   +1 more source

Biosimilar insulins: Narrative review of the regulatory framework and registration studies. [PDF]

Diabetes Obes Metab
Abstract Biosimilar insulins have been commercially available in the EU since 2014. Currently, six biosimilar insulins are approved in the EU and four in the US. However, commercial success has been limited, which may be in part due to concerns among physicians and people with diabetes that biosimilar insulins are substandard in efficacy, safety, and ...
Heise T, DeVries JH.
europepmc   +2 more sources

Phase II study evaluating the safety and efficacy of neratinib and trastuzumab biosimilar in patients with HER2 mutated advanced solid tumors: KCSG AL20‐17/KM23 trial

Cancer Communications, EarlyView.
Kyoungmin Lee, Kyung‐Hun Lee, Dong‐Wan Kim, Jeesun Yoon, Yoon Ji Choi, Soohyeon Lee, Ju Won Kim, Kyong Hwa Park, Wonyoung Choi, Youngjoo Lee, Hyewon Ryu, Dong‐Hoe Koo, YunGyoo Lee, Hei‐Cheul Jeung, Min‐Young Lee, Namsu Lee, Myoung Joo Kang, Jieun Lee, Sook Hee Hong, Eun Joo Kang, In Hae Park   +20 more
wiley   +1 more source