50 results for ADME

Streamlining the Delivery of 14C Human ADME Data: An ADME Q&A Roundtable

Experts from Quotient Sciences and The Netherlands Organization for Applied Scientific Research (TNO) discuss streamlining human ADME studies.

A Decade of Human ADME at Quotient Sciences: Reviewing Key Study Design Variables and Outcomes

A Decade of Human ADME at Quotient Sciences: Reviewing Key Study Design Variables and Outcomes.

Human ADME

Astrazeneca - 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.

Development of a novel oral suspension formulation of a candidate API for administration to pediatric patients

Development of a novel oral suspension formulation of a candidate API for administration to pediatric patients.

Synthesis to Clinic: A streamlined approach to 14C human ADME studies

We are a leading provider of 14C-enabled drug development programs, successfully conducting over 350 human ADME and other radiolabeled programs to date. Learn about Synthesis-to-Clinic®.

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

ADME 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.

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.

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.

Case Studies: Stealth BioTherapeutics

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.

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.

Stable Isotope Labelling Case Study

Multiple, biotechnology and large-pharma companies needing isotope labelling support for their ADME/hAME studies

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.

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.

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.

ISSX Conference 2023 | Boston, MA

Join us for our exhibit and poster presentations at ISSX 2023 in Boston. Meet us there!

Astrazeneca - Mass balance recovery and disposition of AZD4831 in humans

Quotient Sciences and Astrazeneca Co-Authored Scientific Publication evaluating the mass balance recovery and disposition of AZD4831 in humans.

Astrazeneca - A Phase 1 Study to Evaluate Absolute Bioavailability and Absorption, Distribution, Metabolism and Excretion of Savolitinib in Healthy Male Volunteers

Quotient Sciences and Astrazeneca Co-Authored Scientific Publication evaluating Savolitinib in healthy male volunteers.

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

AAPS 2023 Seminar: How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®

During AAPS 2023, we will be hosting a seminar entitled, 'How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®'. There are limited spaces available. Register today.

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 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.

Lunch Seminar in Boston with Charles River and Quotient Sciences

Join experts from Charles River & Quotient Sciences for a complimentary lunch seminar in Boston on the 6th June. Please register early to avoid missing out!

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

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.

Webinar: How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®

Learn about the Translational Pharmaceutics approach and hear insights from our team. Join our webinar in October 2023.

Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development | San Diego

Our pediatric seminar series is returning to California this fall. Register to join us in San Diego.

Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development | South San Francisco

Our pediatric seminar series is returning to California this fall. Register to join us in South San Francisco.

Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development | Belmont

Our pediatric seminar series is returning to California this fall. Register to join us in Belmont.

CPHI 2023 Seminar: How To Accelerate Drug Product Optimization: Integrated Program Delivery Using Translational Pharmaceutics®

During CPHI 2023, we will be hosting a seminar entitled, 'How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®'. There are limited spaces available. Register today.

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.

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

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

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

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.

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).

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