The objective of antibody-drug conjugate (ADC) bioanalysis at different stages of drug development may vary and so are the associated bioanalytical challenges. While at early drug discovery stage involving candidate selection, optimization and preliminary nonclinical assessments, the goal of ADC bioanalysis is to provide PK, toxicity and efficacy data that assists in the design and selection of potential drug candidates, the late nonclinical and clinical drug development stage typically involves regulated ADC bioanalysis that delivers TK data to define and understand pharmacological and toxicological properties of the lead ADC candidate. Bioanalytical strategies and considerations involved in developing successful ligand binding assays for ADC characterization from early discovery to late nonclinical stages of drug development are presented here.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.4155/bio.15.107 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
[Aceneuraminic acid for distal myopathy].
Nihon Yakurigaku Zasshi
January 2025
Department of Neurology, Tohoku University School of Medicine.
Distal myopathy with rimmed vacuoles (GNE myopathy) is an incurable disease that develops after the late teens, progresses slowly, and has no effective treatment. It is inherited in an autosomal recessive manner, and the number of patients in Japan is estimated to be around 400. The causative gene was revealed to be GNE, the rate-limiting enzyme in the sialic acid biosynthesis pathway, and non-clinical studies demonstrated the effectiveness of sialic acid.
View Article and Find Full Text PDFDevelopment of a Self-Care Autonomy in Health Scale for Late Adolescents.
Child Care Health Dev
January 2025
Laboratory of Sports Studies, HSE University, Moscow, Russian Federation.
Background: This paper describes the development of the Self-Care Autonomy in Health Scale for Late Adolescents (SAHSLA) for use with general samples. It addresses concerns regarding the nonclinical efficacy of self-care health scales for adolescents, particularly their ability to discriminate between lower levels of self-care.
Methods: A survey was constructed based on literature review and subsequently evaluated in two studies.
Is Racism a Barrier to HIV Care Continuum Engagement among Black People in the US?: A Scoping Review to Assess the State of the Science and Inform a Research Agenda.
Epidemiol Rev
December 2024
Department of Public Health Sciences, University of Chicago, Chicago, IL.
People living with HIV (PLWH) can achieve VS through timely HIV care continuum (HCC) engagement (ie, diagnosis, linkage to HIV care, retention in care and adherence to prescribed treatment regimens). Black populations have poorer VS, suboptimal HCC engagement and higher levels of racism-related mistrust. This paper assessed the state of the evidence linking sub-optimal HCC engagement to racism among US Black populations.
View Article and Find Full Text PDFUse of artificial intelligence to detect dental caries on intraoral photos.
Quintessence Int
November 2024
Dental caries is one of the most common diseases globally and affects children and adults living in poverty who have limited access to dental care the most. Left unexamined and untreated in the early stages, treatments for late-stage and severe caries are costly and unaffordable for socioeconomically disadvantaged families. If detected early, caries can be reversed to avoid more severe outcomes and a tremendous financial burden on the dental care system.
View Article and Find Full Text PDFEvaluation of Marburg Virus Medical Countermeasures in Guinea Pigs.
Methods Mol Biol
November 2024
Galveston National Laboratory, University of Texas Medical Branch, Galveston, TX, USA.
Various animal models have been established to gain a better understanding of the pathogenesis of Marburg virus (MARV) and Ravn virus (RAVV), and to develop medical countermeasures (MCMs) against them. Of these models, which range from rodents to nonhuman primates (NHPs), the macaque model most closely mimics the severe disease displayed in humans. Nevertheless, rodent models mirror many key aspects of human infection and are frequently used for the initial assessment of experimental vaccines and treatments.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!