A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Assess Safety, Tolerability & Pharmacokinetics (PK) of Amilo-5MER in Healthy Volunteers.
"A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Assess Safety, Tolerability & Pharmacokinetics (PK) of Amilo-5MER in Healthy Volunteers." The poster was presented at the Pharmacology 2022 conference and was co-authored with our customer, Galmed Pharmaceuticals
BPS 2022 Poster - A Phase 1 Randomized PK Study of Amilo-5MER
A Phase 1, Randomized, Double-Blind, PlaceboControlled, First-in-Human Study to Assess Safety, Tolerability & Pharmacokinetics (PK) of Amilo-5MER in Healthy Volunteers
Assessment of the Contribution of CYP2D6 to the Elimination of Idalopirdine as well as the Absolute Bioavailability Following Multiple Oral Dosing
This study assessed the contribution of CYP2D6 to the metabolization of idalopirdine by comparing pharmacokinetics in CYP2D6 extensive metabolizers (EM) and poor metabolizers (PM) following multiple oral dosing. Comparison of pharmacokinetic (PK) parameters in PMs and EMs may substitute for an interaction study of the effect of CYP2D6 inhibition
Peptide Development Strategies
Peptide drug products continue to gain popularity in the pharmaceutical industry due to their high selectivity, high potency, and good safety profile. However, formulating peptides can present many challenges for drug developers because of their unique physicochemical properties.
Applications of Lipid-based Formulations and the Benefits of Integrating Manufacturing and Clinical Testing in Formulation Selection
The purpose of this study is to analyze pharmaceutical and clinical data from multiple development programs to understand the drivers and outcomes of selecting and dosing different lipid formulations.
Peer Reviewed Publication
CC-99677, A Novel, Oral, Selective Covalent MK2 Inhibitor, Sustainably Reduces Pro-inflammatory Cytokine Production
Dr. Stuart Mair, Global Vice President, Medical, Early Development, has contributed to a scientific article on Arthritis Research & Therapy. Mitogen-activated protein kinase (MAPK)-activated protein kinase-2 (MK2) is activated downstream of p38 MAPK and regulates stability of mRNAs encoding inflammatory cytokines.
Non-Clinical vs Clinical: Risks & Considerations When Developing Modified Release Dosage Forms
Join Dr. Vanessa Zann, Senior Drug Development Consultant, Drug Development Consulting at Quotient Sciences. In this webinar, the Dr. Zann will use case studies to describe the specialized formulation technologies that are available in the “toolbox” to achieve an optimal target product profile, and the use of innovative, adaptive clinical programs where human PK data is used to optimize modified release formulation compositions in real-time.
Modified-Release Formulation Strategies
With over 30 years of formulation expertise and over 100 MR programs developed, the team at Quotient Sciences possess the experience, capabilities, and technologies needed to create a successful MR formulation.
Peer Reviewed Publication
New Study Article: Absorption, metabolism and excretion of opicapone in human healthy volunteers
Nand Singh, Medical Director contributions to Bial Study Paper. This paper documents the study - absorption, metabolism and excretion of opicapone (2,5-dichloro-3-(5-[3,4-dihydroxy-5-nitrophenyl]-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide), a selective catechol-O-methyltransferase inhibitor investigations.
Why Archiving is a Crucial Part of Any Clinical Trial
A Quotient Sciences Poster by Erika Reategui, Director, GCP Quality Assurance, Quality Assurance: Why Archiving is a Crucial Part of Any Clinical Trial
Moving Drug Substance Off the Critical Path — Streamlined Strategies to Accelerate to First-in-Human & Beyond
Join Dr. Stephen McQuaker, Director of Drug Development Consulting, as he explores case studies to demonstrate how drug substance and drug product development plans can be accelerated through innovative science and expertise to get drug substance off the critical path.
Overcoming Complex Formulation Challenges: Integrated Strategies for Poor Solubility, Modified Release & Pediatrics
Watch our on-demand webinar featuring John McDermott, Executive Director of Drug Development Consulting at Quotient Sciences, who discusses how an integrated program design can simplify development processes for complex molecules and reduce overall costs.