Urinary markers differentially associate with kidney inflammatory activity and chronicity measures in patients with lupus nephritis.

Objective: Lupus nephritis (LN) is diagnosed by biopsy, but longitudinal monitoring assessment methods are needed. Here, in this preliminary and hypothesis-generating study, we evaluate the potential for using urine proteomics as a non-invasive method to monitor disease activity and damage. Urinary biomarkers were identified and used to develop two novel algorithms that were used to predict LN activity and chronicity.

Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial.

Purpose: In the phase III ADAURA trial, adjuvant treatment with osimertinib versus placebo, with/without prior adjuvant chemotherapy, resulted in a statistically significant and clinically meaningful disease-free survival benefit in completely resected stage IB-IIIA EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQoL) outcomes from ADAURA.

Patients And Methods: Patients randomized 1:1 received oral osimertinib 80 mg or placebo for 3 years or until recurrence/discontinuation.

Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC.

Introduction: Adjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a clinically meaningful improvement in disease-free survival (DFS) in patients with resected stages IB to IIIA EGFR-mutated (EGFRm) NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA.

A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer.

Here, we summarize the initial results from the ADAURA clinical study looking at treatment with osimertinib in patients with a specific type of non-small cell lung cancer (also called NSCLC). Osimertinib (TAGRISSO®) is a medication used to treat a type of NSCLC with a change (mutation) in the EGFR gene, known as EGFR-mutated NSCLC. EGFR stands for 'epidermal growth factor receptor'.

Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for -mutated resectable non-small-cell lung cancer: NeoADAURA.

Osimertinib is a third-generation, irreversible oral EGFR-tyrosine kinase inhibitor), that potently inhibits EGFR-tyrosine kinase inhibitor-sensitizing mutations and T790M resistance mutations together with efficacy in CNS metastases in patients with non-small-cell lung cancer (NSCLC). Here we describe the rationale and design for the Phase III NeoADAURA study (NCT04351555), which will evaluate neoadjuvant osimertinib with or without chemotherapy versus chemotherapy alone prior to surgery, in patients with resectable stage II-IIIB N2 mutation-positive NSCLC. The primary end point is centrally assessed major pathological response at the time of resection.

Development of a mechanism of action-reflective, dual target cell-based reporter bioassay for a bispecific monoclonal antibody targeting human CTLA-4 and PD-1.

T-cell-mediated immunotherapy has generated much excitement after the success of therapeutic biologics targeting immune checkpoint molecules. Bispecific antibodies (BsAbs) that recognize two antigen targets are a fast-growing class of biologics offering promising clinical benefits for cancer immunotherapy. Due to the complexity of the molecule structure and the potential mechanism of action (MOA) that involves more than one signaling pathway, it is critical to develop appropriate bioassays for measuring potency and characterizing the biological properties of BsAbs.

Osimertinib in Resected -Mutated Non-Small-Cell Lung Cancer.

Background: Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor () mutation-positive advanced non-small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown.

Methods: In this double-blind, phase 3 trial, we randomly assigned patients with completely resected mutation-positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years.

The Phase Relations of the Co-Ni-In Ternary System at 673 K and 873 K and Magnetic Properties of Their Compounds.

The phase relationships of the ternary Co-Ni-In system at 673 K and 873 K were investigated by means of powder X-ray diffraction, scanning electron microscopy equipped with energy dispersive spectroscopy, and optical microscopy. Though CoIn does not exist at 873 K, the ternary solid solution CoNiIn exists at both 673 K and 873 K with different composition ranges. The Rietveld refinements were carried out to investigate the crystal structure of CoNiIn (x = 0.

Comparisons of outlier tests for potency bioassays.

Potency bioassays are used to measure biological activity. Consequently, potency is considered a critical quality attribute in manufacturing. Relative potency is measured by comparing the concentration-response curves of a manufactured test batch with that of a reference standard.

Effect of a statistical outlier in potency bioassays.

The USP<1032> guidelines recommend the screening of bioassay data for outliers prior to performing a relative potency (RP) analysis. The guidelines, however, do not offer advice on the size or type of outlier that should be removed prior to model fitting and calculation of RP. Computer simulation was used to investigate the consequences of ignoring the USP<1032> guidance to remove outliers.

Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.

Changes of manufacturing processes are common. It is required by the regulatory agencies that manufacturers establish adequate and appropriate comparability between pre-change and post-change products. The goals of comparability assessments are to demonstrate the comparability and consistency of product quality before and after change and to demonstrate that the changes do not have an adverse effect on safety and efficacy of the drug products.

Quantitative X-ray Diffraction (QXRD) analysis for revealing thermal transformations of red mud.

Red mud is a worldwide environmental problem, and many authorities are trying to find an economic solution for its beneficial application or/and safe disposal. Ceramic production is one of the potential waste-to-resource strategies for using red mud as a raw material. Before implementing such a strategy, an unambiguous understanding of the reaction behavior of red mud under thermal conditions is essential.

Statistical methods in integrative analysis for gene regulatory modules.

We propose a suite of statistical methods for inferring a cis-regulatory module, which is a combination of several transcription factors binding in the promoter regions to regulate gene expression. The approach is an integrative analysis that combines information from multiple types of biological data, including genomic DNA sequences, genome-wide location analysis (ChIP-chip experiments), and gene expression microarray. More specifically, we use a hidden Markov model to first predict a cluster of transcription factor binding sites in DNA sequences.