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32 results for "Early Development"

CureSearch Pediatric Early Development Symposium

Join Nazim Kanji as he presents at the CureSearch Pediatric Early Development Symposium from 1st-2nd October 2020

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.

How can you conserve cash and still accelerate to your key early development milestones?

This webinar will explore some of the challenges faced by industry today and discuss how early drug development timelines can be accelerated, whilst at the same time conserving cash flow.

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.

The Role of Biopharmaceutics in Early Drug Development

This webinar discusses effective strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explores 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.

Integrated Early-Stage Drug Development and Manufacturing: Accelerating Molecules to Proof-of-Concept

This webinar highlights how by breaking down the barriers between traditional outsourcing channels and workflows, drug development activities and key functional groups including formulation development, manufacturing and clinical research can be much more closely integrated to accelerate early-stage drug development, reduce overall expenditure and shorten time to proof of concept.

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.

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.

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.

10th American DDF Summit

Discuss your drug development requirements with us at the 10th American Drug Delivery and Formulation event on December 14 & 15

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)

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.

Drug Product Strategies to Accelerate from Candidate Selection to Proof-of-Concept

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

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

Translational Pharmaceutics and the Benefits of Real-Time Adaptive Manufacturing

This webinar explains the benefits of Translational Pharmaceutics, a unique approach which integrates formulation development, real-time adaptive GMP manufacturing and clinical research. It will illustrate how, by breaking down the siloes and integrating horizontally, we can operate with more flexibility in the early phases of drug development, reducing costs and shortening timelines.

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.

Formulation strategies for poorly soluble molecules - Pharmaceutics and biopharmaceutics considerations

This presentation uses expert insight and case studies to explore formulation and solubility challenges and discuss the best strategies and technologies for advancing poorly soluble molecules, to deliver success.

BioPharm America 2020 Virtual Partnering Conference

Schedule a partnering meeting with our CSO, Peter Scholes at BioPharm America to discuss you drug development needs.

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.

Maximising Formulation Flexibility in First-in-Human Trials

This edition of OBN’s Digital Event series is being organized in collaboration with Quotient Sciences and will highlight how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.

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.

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.

Considerations for First-In-Human Clinical Trials: Planning for Success

The First-in-human (FIH) clinical trial is a pivotal milestone in the drug development process and is the stage-gate before molecules can proceed to Phase II/proof of concept trials.

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