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48 results for "Early Development"

Integrated Programs: Early Development

Simplify early development and accelerate to Proof-of Concept Proof-of-Concept (POC) is a key milestone in the development of a new drug candidate. At Quotient Sciences, we understand the increasing pressures on R&D budgets, therefore the need to transition molecules through early development to POC needs to be fast and cost-effective.

Early Development

Application of Translational Pharmaceutics® to reduce time, cost and risk in the early development of inhaled drug products - RDD

The efficiency and effectiveness of new drug development has remained problematic over the last decade. Translational Pharmaceutics has emerged as a new paradigm to improve R&D productivity.

Accelerating molecules through to Proof-of-Concept, with an integrated early development program

This webinar highlights how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.

Accelerating drug product development from early phase to scale up and commercialisation

This webinar covers a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT.

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.

Getting it Right Early- The Importance of Biopharmaceutics in Early Drug Development - Webinar

Join us for a webinar 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.

Adaptive manufacturing: a new paradigm to improve efficiency and effectiveness in early oncology development - AAPS 2014

There is an unmet need in the industry for a more efficient and flexible approach to provide drug product for early clinical studies. Presented here is an innovate approach to overcome these challenges by utilising a real-time, adaptive manufacturing and supply platform.

14C Microtracer approaches to inform formulation development strategies in early clinical drug development - AAPS 2016

This poster describes how combining an intravenous (IV) microtracer regimen with an oral tracer regimen, can generate key pharmacokinetic (PK) parameters.

Real-time drug product manufacturing to enable accelerated early clinical development of spray dried dispersion based formulations - AAPS 2017

This poster describes how adopting a real-time drug product manufacturing approach allowed initiation of the FIH study within 12 weeks of initiating SDD process transfer.

Flow Chemistry for Accelerated Drug Substance Delivery

This webinar discusses drug substance manufacturing in early development and the very concept of being fast, agile and innovative.

Clinical Pharmacology

When you are looking for a partner who is dedicated to Phase I trials and early development, rely on Quotient Sciences. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier.

Developing spray dried dispersions for early phase clinical trials and beyond

Formulation strategies and the DevelopabilityClassification System (DCS). Benefits of spray-drying to address poor drug solubility. Fit-for-purpose systems in early clinical research and effectively transitioning to solid oral dosage forms. Adaptive clinical manufacturing “tailored” to the clinical study and patient recruitment.

First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines

Increasing pressure on R&D budgets means the design, speed and precision of early phase clinical programs is critical for success.

DCAT Week 2022

Schedule an in-person or digital meeting with our drug development experts during DCAT week in NYC

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.

Peptide Development Webinar - July 20th

Register today for our upcoming Peptide Development webinar taking place on July 20th, entitled- Accelerating Peptide Development: Strategies to optimize the formulation & manufacture of peptide therapeutics

Peptide Development Webinar - July 22nd

Register today for our upcoming Peptide Development webinar taking place on Thursday, July 22nd, entitled- Accelerating Peptide Development: Strategies to optimize the formulation & manufacture of peptide therapeutics

Peptide Development Webinar - July 15th

Register today for our upcoming Peptide Development webinar taking place on Thursday, July 15th, entitled- Accelerating Peptide Development: Strategies to optimize the formulation & manufacture of peptide therapeutics

Accelerating Peptide Development Webinar Series

Register today for our Peptide Development webinar series taking place on July 15th, 20th & 22nd, entitled- Accelerating Peptide Development: Strategies to optimize the formulation & manufacture of peptide therapeutics

Accelerating Peptide Development: Strategies to optimize the formulation and manufacture of peptide therapeutics

This webinar reviews the challenges when developing a peptide formulation, investigates the best route of delivery for your molecule, alongside looking into formulation strategies and manufacturing considerations, before exploring options for an integrated approach to accelerate peptide development.

From candidate selection through to proof-of-concept

Building a robust understanding of your API characteristics matched against your development programme goals, supports the efficient transition of drug products from candidate selection through to proof-of-concept. Starting @ 4pm (BST-UK), 11pm (ET), 8am (PT) and 6pm (BST-UK), 1pm (ET), 10am (PT)

CPhI Worldwide

Quotient will be attending CPhI Worldwide 2021 from November 9-11, 2021.

Development of a Modified Release Tablet Containing an API Prone to Form Changes and Gelling in Aqueous Media

Development of an MR formulation of Cmp-1 was planned using RapidFACT®: an integrated approach that allows formulation optimization based on human PK data with an adaptive clinical design. Selection of a discriminatory in vitro dissolution test was an important early development activity.

Clinical Pharmacology

JPAG Stability Symposium

Quotient Sciences' will be attending the JPAG Stability Symposium on June 30, 2022.

AAPS 2020 Poster - A Quality by Deisgn Approach to Optimize and Accelerate Formulation and Process Development Leading towards Registration Batches Manufacturing

To improve the existing formulation composition and manufacturing process of compound X which was designed for early phase development Process optimization activities focused on improving the flow characteristics of the granules, minimizing or eliminating segregation and increasing the manufacturing yield with the aim of achieving a robust process prior to the product registration campaign.

Bioanalytical Services

Determining drug exposure is vital for the assessment of drug safety and efficacy. Quotient's Bioanalytical team, develop and refine methods so exposure can be assessed reliably and accurately in a variety of biological matrices.

Bioanalytical services to accelerate drug development

Delivering rapid bioanalytical data is critical to drug development. From drug discovery, through to preclinical and clinical studies, understanding drug exposure and behavior are imperative to dose selection, and accelerating drugs to clinic and commercialization. Through the use of robust bioanalytical techniques, biological samples can be processed and analyzed to identify and quantify compounds of interest, such as small molecules and their metabolites, as well as peptides, proteins, nucleic acids and other analytes.

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.

Live Webinar: Improving Solubility and Accelerating Drug Development through Integrated Programs

Join Quotient & Lonza on February 23rd at 8am PST / 11am EST for a live webinar entitled: Improving Solubility and Accelerating Drug Development through Integrated Programs

Solubility Webinar October 21st

Register today for our solubility focused webinar on October 21st.

Solubility Webinar Series

Register today for our solubility focused webinar series taking place on October 21st, 26th, or 28th for our Solubility focused webinar entitled: Accelerated development strategies for poorly soluble molecules

Solubility Webinar October 26th

Register today for our solubility focused webinar on October 26th.

Solubility Webinar October 28th

Register today for our upcoming solubility focused webinar on October 28th.

Solubilizing the insoluble - Royal Society of Chemistry Event

Join Quotient at the virtual Solubilizing the insoluble - Formulation approaches event on December 2, 2021

CPhI NA Lunch Seminar: Moving Drug Substance Off the Critical Path

Save your spot at our CPhI North America lunch seminar on May 18, entitled: Moving Drug Substance Off the Critical Path- Streamlined Strategies to Accelerate to First-in-Human & Beyond

Upcoming Live Webinar: Overcoming formulation challenges for complex programs: Integrated strategies for Poor Solubility, Modified Release & Pediatrics

Drug development for any molecule type is challenging, given the numerous stages an active lead molecule or new chemical entity (NCE) must transition through to gain regulatory approval and reach patients to demonstrate its benefits. For more complex molecules that may require having solubility enhancement or specialized formulation expertise like modified release or a pediatric program, the challenges in achieving clinical and commercial success are even greater.

Overcoming Complex Formulation Challenges: Integrated Strategies for Poor Solubility, Modified Release & Pediatrics

Watch our On Demand Webinar featuring Quotient Sciences' Executive Director of Drug Development Consulting, John McDermott, as he discusses how an integrated program design can simplify development processes for complex molecules and reduce overall costs.

Clinical Trial Manufacturing

Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient Sciences offers clinical trial manufacturing, testing and certification services designed to meet your individual requirements.

Pre-formulation screening

Pre-formulation screening

Pre-formulation screening

Enhanced formulation decision-making in early phase clinical trials for parenteral products

This presentation describes the principles and applications of Translational Pharmaceutics: an R&D platform integrating formulation development, real-time adaptive GMP manufacturing and clinical testing in order to accelerate drug development cycles.

BIO Happy Hour Seminar: Moving Drug Substance Off the Critical Path

Save your spot at our BIO Happy Hour seminar on June 15th, entitled: Moving Drug Substance Off the Critical Path- Streamlined Strategies to Accelerate to First-in-Human & Beyond

BIO International 2022 Happy Hour Seminar: Moving Drug Substance Off the Critical Path

Save your spot at our BIO happy hour seminar on June 15, "Moving Drug Substance Off the Critical Path- Streamlined Strategies to Accelerate to First-in-Human & Beyond."

Moving Drug Substance Off the Critical Path — Streamlined Strategies to Accelerate to First-in-Human & Beyond

Join Quotient’s Director of Drug Development Consulting, Dr Stephen McQuaker Vice President of Bioanalysis, Dr Stuart McDougall, 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.

AAPS 2019 Poster- Applications and Benefits of Healthy Volunteer Trials to Accelerate Oncology Drug Development

Presented at AAPS 2019: Phase I drug development for oncology compounds is traditionally conducted directly in patient populations. Oncology molecules have historically been cytotoxic, meaning their safety and risk:benefit profile makes them unviable for dosing in healthy subjects. While this ensures reduced nonclinical requirements, rapid access to patient data and an earlier assessment of efficacious potential, it can also present challenges. For example, patients recruited in Phase I trials typically are at end of life care and will be taking multiple co-medications and have multiple co-morbidities (e.g. liver and kidney function may vary greatly among the recruited subjects). Practically, recruiting patients into Phase I studies can also be problematic, requiring multiple clinical sites and protracted recruitment times for what would traditionally be single site, quickly recruited healthy volunteer studies.

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