[HTML][HTML] Rabbit as an animal model for intravitreal pharmacokinetics: Clinical predictability and quality of the published data

EM Del Amo, A Urtti - Experimental eye research, 2015 - Elsevier
Intravitreal administration is the method of choice in drug delivery to the retina and/or
choroid. Rabbit is the most commonly used animal species in intravitreal pharmacokinetics …

[HTML][HTML] Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies

AV Kamath - Drug Discovery Today: Technologies, 2016 - Elsevier
Monoclonal antibodies (mAbs) are an important therapeutic class with complex
pharmacology and interdependent pharmacokinetic (PK) and pharmacodynamics (PD) …

Immunogenicity of protein pharmaceuticals

R Dingman, SV Balu-Iyer - Journal of pharmaceutical sciences, 2019 - Elsevier
Protein therapeutics have drastically changed the landscape of treatment for many diseases
by providing a regimen that is highly specific and lacks many off-target toxicities. The clinical …

Immunogenicity assessment during the development of protein therapeutics

AS Rosenberg, ZE Sauna - Journal of Pharmacy and …, 2018 - academic.oup.com
Objective Here we provide a critical review of the state of the art with respect to non-clinical
assessments of immunogenicity for therapeutic proteins. Key findings The number of studies …

A new era for migraine: pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody

W Kielbasa, DL Helton - Cephalalgia, 2019 - journals.sagepub.com
Purpose To review pharmacokinetic and pharmacodynamic characteristics of antibodies that
bind to soluble ligands within the framework of calcitonin gene-related peptide antibodies …

Understanding inter-individual variability in monoclonal antibody disposition

VA Thomas, JP Balthasar - Antibodies, 2019 - mdpi.com
Monoclonal antibodies (mAbs) are currently the largest and most dominant class of
therapeutic proteins. Inter-individual variability has been observed for several mAbs; …

Potential sources of inter-subject variability in monoclonal antibody pharmacokinetics

KL Gill, KK Machavaram, RH Rose, M Chetty - Clinical pharmacokinetics, 2016 - Springer
Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is
important to ensure that all patients attain suitable drug exposure to achieve efficacy and …

Therapeutic outcomes, assessments, risk factors and mitigation efforts of immunogenicity of therapeutic protein products

L Yin, X Chen, P Vicini, B Rup, TP Hickling - Cellular Immunology, 2015 - Elsevier
Therapeutic protein products (TPPs) are of considerable value in the treatment of a variety of
diseases, including cancer, hemophilia, and autoimmune diseases. The success of TPP …

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative …

Clinical & Experimental Immunology, 2015 - academic.oup.com
Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational
drug therapies that is contributing significantly to advancing treatment in multiple disease …

A minimal physiologically based pharmacokinetic model that predicts anti-PEG IgG-mediated clearance of PEGylated drugs in human and mouse

MD McSweeney, T Wessler, LSL Price… - Journal of Controlled …, 2018 - Elsevier
Circulating antibodies that specifically bind polyethylene glycol (PEG), a polymer routinely
used in protein and nanoparticle therapeutics, have been associated with reduced efficacy …