Resource Centre

In this whitepaper, Quotient Sciences highlights the key challenges that arise in pediatric formulation development, offers potential solutions, and discusses future trends and regulatory aspects that can help streamline pediatric medicines to patients faster.

A core component of Quotient Sciences is our integrated capabilities in drug substance process research, development, and manufacturing. All are carried out at our state-of-the-art facility in Alnwick, UK.

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®.

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.

MR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.

Worldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.

Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.

Modified-release (MR) formulations are in high demand. For formulators, they enable drugs to be released in the optimal gastrointestinal (GI) locations to achieve and maintain desirable plasma concentrations for extended periods, avoiding undesirable excursions outside the therapeutic range.

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

This white paper describes the benefits of our approach to poorly soluble drugs in terms of drug product performance and clinical decision-making, including case studies that demonstrate significant time and cost savings.