AAPS Open
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Antibody-drug conjugates: integrated bioanalytical and biodisposition assessments in lead optimization and selection
AAPS Open - Tập 4 - Trang 1-17 - 2018
Therapies based on monoclonal antibodies (mAbs) have delivered an impressive success in the clinics due to their exquisite specificity, potential for agonistic or antagonistic responses, tunable effector function, and optimal pharmacokinetic properties. Building on these inherent antibody properties, the design and development of antibody-drug conjugates (ADCs) with improved or gained therapeutic ......
Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia
AAPS Open - Tập 4 - Trang 1-14 - 2018
Inotuzumab ozogamicin (InO) is an antibody-drug conjugate composed of a recombinant, humanized immunoglobulin type G, subtype 4 (IgG4) antibody covalently bound to a semisynthetic derivative of calicheamicin via an acid-labile linker. It was developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). Based on the perceived relatively low......
Designing an ideal alcohol-based hand sanitizer: in vitro antibacterial responses of ethanol and isopropyl alcohol solutions to changing composition
AAPS Open - Tập 7 - Trang 1-11 - 2021
This study aimed to achieve an in vitro quantification of the effects of composition and formulation factors on the killing rates of alcohol-based hand sanitizers. The killing rates of 85% ethyl alcohol (ET) and isopropyl alcohol (IPA) were studied under different conditions such as pH, electrolyte concentration, or inclusion of herbal extracts (cucumber, carrot, and aloe vera), a quaternary ammon......
Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis
AAPS Open - Tập 3 - Trang 1-10 - 2017
While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in which patients experience medications in real world settings. However, the relationship between these two data sources has not been closely examined. To understand how rates of medication sid......
The journey to AAPS 2020: a reflection from strategic planning to PharmSci 360
AAPS Open - Tập 4 - Trang 1-4 - 2018
Understanding the implication of Kawakita model parameters using in-die force-displacement curve analysis for compacted and non-compacted API powdersAbstract The aim of this study was to investigate powder mechanics upon compression using data obtained from force-displacement (F-D) curves. The Kawakita model of powder compression analysis was adopted in order to compare the pressure-volume reduction relationship of the drug powders in relation to the F-D curves. Experiments were carried out on six model drugs (m... ...
AAPS Open - Tập 8 Số 1 - 2022
Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report
AAPS Open - Tập 8 - Trang 1-7 - 2022
This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to the American Association of Pharmaceutical Scientists (AAPS) PharmSci360 Congress, San Antonio, TX, November 2019. The purpose of the workshop was to bring together thought leaders in biomarker assay development in order to identif......
Development and evaluation of taste masked dry syrup formulation of potassium chloride
AAPS Open - - 2019
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid
AAPS Open - Tập 8 - Trang 1-9 - 2022
The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products: Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid (PQAAid). The panel sessions were held on August 27, 2021, for the discu......
Strategies to stabilize dalbavancin in aqueous solutions: Section 4—identification of heat degradation products in 2-hydroxypropyl-β-cyclodextrin and divalent metal ion solutions at pH 4.5 and 7.0Abstract Heat stress studies have been conducted in support of developing a heat-stable liquid solution of dalbavancin. The degradation products that form in heat-stressed buffered dalbavancin solutions have been identified, including the known major degradation product, mannosyl aglycone (MAG), and four previously uncharacterized compounds. Liquid chromatography-ma... ...
AAPS Open -
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