PROFILING AND CHARACTERIZATION OF ZD10Q AND METABOLITES IN RAT, DOG, MONKEY, AND HUMAN HEPATOCYTES
The QPS study was conducted to investigate the metabolism ZD10Q in the Sprague Dawley rat, Beagle dog, Cynomolgus monkey, and human using pooled cryopreserved hepatocyte suspensions.
MODIFICATION OF SMALL MOLECULE DRUG METHODS TO CONFIRM DRUG SAFETY OF LARGE DOUBLE STRANDED SIRNA BIOTHERAPEUTICS
QPS used three commercial double stranded siRNA drugs in a series of inter-species, in vitro, qualitative and quantitative metabolite characterization experiments using modified small molecule procedures to confirm internal process to establish similar confidence for MIST.
OPTIMIZATION OF A 40-COLOR HIGH-DIMENSIONAL FLOW CYTOMETRY PANEL TO SIMULTANEOUSLY EVALUATE ACTIVATION-INDUCED MARKERS AND CYTOKINES IN HUMAN PERIPHERAL BLOOD MONONUCLEAR CELLS
With the increasing requirements for monitoring cellular immune responses during clinical trials, QPS previously developed a comprehensive 40-color high-dimensional flow cytometry panel to assess various cellular immune responses.
RESULTS OF A PHASE 1 CLINICAL TRIAL (GH001-HV-103) TO DETERMINE THE SAFETY AND TOLERABILITY OF MEBUFOTENIN (5-MEO-DMT), ADMINISTERED VIA INHALATION (GH001) IN HEALTHY SUBJECTS
QPS and GH enrolled healthy volunteers for a Phase I trial to determine the safety and tolerability of a single administration or a single-day IDR of GH001.
PHARMACOKINETICS OF THB001, AN ORALLY AVAILABLE, POTENT AND HIGHLY SELECTIVE SMALL MOLECULE INHIBITOR OF WILD TYPE KIT RECEPTOR TYROSINE KINASE, IN HEALTHY VOLUNTEERS
Three Phase I studies in healthy volunteers were conducted to monitor KIT inhibitor depletion in mast cell tissues to determine it’s effectiveness in mast cell driven diseases.
CHOOSING AN APPROPRIATE NEUTRALIZING ANTIBODY ASSAY FORMAT: A CASE STUDY IN PARALLEL METHOD DEVELOPMENT OF CELL-BASED AND COMPETITIVE LIGAND BINDING NEUTRALIZING ANTIBODY ASSAYS
The 2019 FDA Immunogenicity Guidance, and Wu, et. al., recommend using a cellbased assay format for neutralizing antibody (NAb) assays when a therapeutic has a cell-based mechanism of action (MoA).
A 40-COLOR HIGH DIMENSIONAL FLOW CYTOMETRY PANEL TO EVALUATE CELLULAR IMMUNE RESPONSES ON VARIOUS T-CELL SUBSETS FROM CRYOPRESERVED HUMAN PERIPHERAL BLOOD MONONUCLEAR CELLS
With the ongoing outbreak of the coronavirus disease COVID-19 in recent years, there has been increased interest into better understanding an individual’s cellular immunity to COVID-19 or any other vaccine or gene therapeutic agent.
RESULTS OF A PHASE 1 CLINICAL TRIAL TO DETERMINE THE SAFETY AND TOLERABILITY OF GH002
Mebufotenin, also known as 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), is a potent psychedelic drug belonging to a group of psychoactive indole-alkylamine drugs.
A PHASE I FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC (PK) PROPERTIES OF THE INTRAVENOUSLY(IV) ADMINISTERED OMN6, A NOVEL ANTIMICROBIAL PEPTIDE TARGETING ACINETOBACTER BAUMANNII (A. BAUMANNII), IN ADULTS INCLUDING OLDER HEALTHY VOLUNTEERS (HVs) SUBJECTS
Acinetobacter baumannii (A. baumannii) is an opportunistic Gram-negative pathogen that is listed as of critical priority on the World Health Organization (WHO) Priority Pathogen list.
