Streamlining the Delivery of 14C Human ADME Data: An ADME Q&A Roundtable
On December 6, 2022, join Quotient Sciences and The Netherlands Organization for Applied Scientific Research (TNO) for an interactive, hour-long live Q&A webinar focused on streamlining human ADME studies.
ADME Q&A Roundtable Webinar- Feb. 8
Register today for our ADME webinar series on February 8th, "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval."
ADME Q&A Roundtable Webinar- Feb. 15
Register today for our ADME focused webinar series taking place on February 15th entitled: "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval"
ADME Q&A Roundtable Webinar- Feb. 10
Register today for our ADME focused webinar series taking place on February 10th entitled: "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval"
ADME Q&A Roundtable Webinar Series
Register today for our ADME focused webinar series taking place on February 10th & 15th entitled: "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval"
Human ADME
Scientific Paper_Pharmacokinetics and Metabolism of Ziritaxestat (GLPG1690) in Healthy Male Volunteers Following Intravenous and Oral Administration
Download our scientific paper entitled: Pharmacokinetics and Metabolism of Ziritaxestat (GLPG1690) in Healthy Male Volunteers Following Intravenous and Oral Administration
AAPS 2019 Poster- Comparison of Two In-Silico Modeling Programs, ADMET Predictor® and Percepta® to Predict Intrinsic Solubility and pKa of Poorly Soluble Drugs
Presented at AAPS 2019: Aqueous solubility is a prerequisite for oral absorption of a drug and the pH-dependence of aqueous solubility is critical information to guide formulation development strategies. The purpose of this study was to evaluate the physical property modules in two commercially available in-silico modelling programs in predicting the pH solubility profiles as described by the ionization constant (pKa) and the intrinsic solubility of the unionized form.
Quotient Sciences_Astrazeneca_Scientific Publication- Characterization of Clinical ADME & Pharmacokinetics of Velsecorat Using an IV Microtracer Combined with an Inhaled Dose in Healthy Subjects
Quotient Sciences and Astrazeneca Co-Authored Scientific Publication evaluating the use of intravenous 14C dosing in healthy volunteer subjects to understand the metabolism for an inhaled drug product.
Human ADME Capabilities
With over 30 years’ experience as a world leading provider of human ADME 14C radiolabeled studies, we have the scientific expertise and operational know-how to design and deliver human ADME programs in preparation for NDA, MAA and global regulatory filings.
Conduct of clinical ADME study for Vosaroxin in oncology patients - AAPS 2015
Conduct of clinical ADME study for Vosaroxin in oncology patients via real-time adaptive manufacture of intravenous drug product.
A Phase I, open-label, 2-Part study to establish absolute bioavailability - DMDG 2016
A Phase I, open-label, 2-Part study to establish absolute bioavailability and the ADME of evogliptin in healthy male subjects by light-label approach.
A randomised double-blind dose escalation study- ASCPT 2016
A randomised double-blind dose escalation study to evaluate the safety and dose response of subcutaneous administration of coversin in healthy subjects.
Phase 1 Studies to Evaluate the Food Effect and Relative Bioavailability of Tablet and Capsule Formulations of Belumosudil in Healthy Adult Subjects
Quotient Sciences and Kadmon co-authored scientific publications on their recent NDA approved drug Belumosudil.
Stable Isotope Labelling Case Study
Multiple, biotechnology and large-pharma companies needing isotope labelling support for their ADME/hAME studies
Quotient Sciences Aseptic Development & Manufacturing Capabilities Info Sheet
Quotient Sciences has expertise in developing, manufacturing, testing, releasing, and supplying a range of formulations (IV, SC, and IM administration) for a variety of clinical study types, including first-in-human (FIH) healthy volunteer studies assessing safety, tolerability, and pharmacokinetics (PK), as well as radiolabeled formulations for human absorption, distribution, metabolism, and excretion (ADME) studies.
AAPS 2019 Poster - Clinical formulation development for poorly soluble 14C labelled molecules
Clinical studies involving the administration of 14C radio labelled drug substances provide critical information during development.The main application is the regulatory ADME study to assess the mass balance, routes and rates of elimination, and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.
Scientific Paper_Development and approval of rybelsus (oral semaglutide): ushering in a new era in peptide delivery
Download our latest scientific publication entitled: Development and approval of rybelsus (oral semaglutide): ushering in a new era in peptide delivery
International Society for the Study of Xenobiotics 2022 (ISSX)
Quotient Sciences will be exhibiting and presenting two posters at the upcoming ISSX 2022 conference September 11-14, 2022.
Dose Finding and Food Effect Studies of a Novel Abiraterone Acetate Formulation for Oral Suspension in Comparison to a Reference Formulation in Healthy Male Subjects
Quotient Sciences & Tavanta Scientific Publication: Dose Finding and Food Effect Studies of a Novel Abiraterone Acetate Formulation for Oral Suspension in Comparison to a Reference Formulation in Healthy Male Subjects
A Clinical Assessment of Delayed-Release Coated Capsule Compositions for Regional Gastrointestinal Delivery using Gamma Scintigraphy
Applied Molecular Transport Inc. are evaluating targeted drug delivery capsules for administration of locally acting drugs directly to the site of action in the gastrointestinal (GI) tract. This study used gamma scintigraphy to evaluate GI transit and release from 3 capsule prototypes with different coating systems (1). In addition, data on pH, temperature and pressure during GI transit was obtained using SmartPill® and correlated with scintigraphy data (2).
Application of a Novel ‘Make and Test in Parallel’ Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects
GDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers.
Aseptic Manufacturing Capabilities
Stealth BioTherapeutics
Stealth BioTherapeutics is using real-time sterile manufacturing to enable a new route of administration.
Clinical Pharmacokinetics and Pharmacodynamics of ME-401 - AACR 2016
Clinical Pharmacokinetics and Pharmacodynamics of ME-401, an Oral, Potent and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ, Following Single Ascending Dose Administration to Healthy Volunteers
Leveraging Bioanalysis to Accelerate Drug Development Programs: Challenges and Considerations
Join Quotient’s Vice President of Bioanalysis, Dr Stuart McDougall, as he discusses how best to leverage bioanalysis within drug development programs to accelerate timelines & enhance the likelihood of clinical & commercial success.
A Phase 1 Pharmacokinetic Drug Interaction Study of Belumosudil Coadministered With CYP3A4 Inhibitors and Inducers and Proton Pump Inhibitors
Quotient Sciences and Kadmon co-authored scientific publications for their recent NDA approved drug Belumosudil.
An integrated radiolabelled study to determine the mass balance, metabolite profile and identification, and absolute bioavailability of nolasiban in healthy female subjects
Quotient Sciences Poster : An Integrated Radiolabelled Study to Determine the Mass Balance, Metabolite Profile and Identification and Absolute Bioavailability of Nolasiban in Healthy Female Subjects
Delivery of Antibodies to the Gastrointestinal Tract for Local Action
There has been increasing interest in the oral administration of antibodies for localised treatment of infections or other conditions in the gastrointestinal (GI) tract.
Getting it Right Early- The Importance of Biopharmaceutics in Early Drug Development - Boston
Join us for a complimentary lunch seminar to learn effective strategies that biotech and pharmaceutical companies are using to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline and explore alternative approaches for accelerating your early development plan.
ACCP: A Phase 1 Pharmacokinetic Drug Interaction Study of Belumosudil Coadministered With CYP3A4 Inhibitors and Inducers and Proton Pump Inhibitors
Quotient Sciences, Kadmon and Nuventra, Co-Authored Scientific Publication assessing Belumosudil, a selective Rho-associated protein kinase 2 inhibitor. Inhibition of Rho-associated protein kinase 2 has emerged as a promising treatment for chronic graft-versus-host disease by restoring immune homeostasis and reducing fibrosis.
Development of a Once‑Daily Modified‑Release Formulation for the Short Half‑Life RIPK1 Inhibitor GSK2982772 using DiffCORE Technology
Quotient Sciences Scientific Publication- Development of a Once‑Daily Modified‑Release Formulation for the Short Half‑Life RIPK1 Inhibitor GSK2982772 using DiffCORE Technology
Flexible strategies for the conduct of human metabolism studies with oncology molecules - ISSX 2014
The key objectives of human ADME studies are to evaluate mass balance, determine the routes and rates of elimination and gain an understanding of the metabolic fate of the drug.
A pharmacoscintigraphic study of the relationship between tablet erosion and pharmacokinetics of oral semaglutide - ADA 2017
When administered orally, peptide-based drugs are susceptible to degradation in the stomach due to exposure to low pH and proteolytic enzymes.
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.
DCS classification of NCE - Case study
US Biotech wanted to determine the DCS (Developability Classification System) designation for their small molecule. This included project scope and outcomes of the project.
BIO International Convention 2022
Meet with Quotient Sciences experts at BIO in San Diego from June 13-16. Also be sure to join us for our drug substance focused happy hour seminar and reception on June 15.
Using 14C radiolabeled clinical studies to explore and evaluate factors influencing oral exposure - ISSX 2017
This poster describes a 2 part study combing an IV microtracer study with a conventional oral ADME study
AAPS 2022 Lunch & Learn Seminar with Charles River
Join experts from Charles River & Quotient Sciences for a complimentary lunch seminar during AAPS on October 18.
Integrated Development Strategies Lunch Seminar- Alnwick, UK
Join senior leaders from Charles River and Quotient Sciences as they discuss how their collaboration helps customers by bringing expert knowledge, removing obstacles from the critical path, reducing development risks, and shortening the pathway to clinical development and beyond. Through case studies they will demonstrate how an integrated program provides customers with the full set of deliverables required to be “clinic ready”, and how this seamless transition between providers can improve the chances of clinical and commercial success.
ISSX NA 2021 - An Integrated Radiolabelled Study to Determine the Mass Balance, Metabolite Profile and Identification and absolute bioavailability of Nolasiban in Healthy Female Subjects
Presented at the 24th North American ISSX Meeting, in this poster, we determine Mass Balance, Metabolite Profile and Identification and Absolute Bioavailability of Nolasiban in Healthy Female Subjects, via an integrated radiolabelled study.
Phase 1/1b study of inhaled formulation in healthy volunteers & asthmatics
PUR1900 is an iSPERSE™ formulation incorporating a large, complex anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects.