A flexible, real-time adaptive GMP manufacturing model is required to support the increasing requirement for clinical trials conducted in small patient populations with challenging trial designs and treatment algorithms.

Download and read our poster titled, 'Enabling Clinical Assessment of Maralixibat for Rare Pediatric Liver Disease via Real-Time Adaptive GMP Manufacturing' here.

Our experts presented posters at the 2017 AAPS Conference.  Check out the science behind the on-stand presentations that we shared with the world.

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

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 to accelerate drug development cycles.

Download our presentation titled, 'Enhanced Formulation Decision-Making in Early Phase Clinical Trials for Parenteral Products.'

The aim of the phase 1, single-center, randomized, active-controlled study in healthy volunteers reported in this paper was to investigate the pharmacodynamic effects and safety of different dosing regimens of RDX7675 in humans.

Request a copy of our scientific poster titled, 'An Evaluation of the Pharmacodynamics, Safety, and Tolerability of the Potassium Binder RDX7675'.

Conventional human metabolism studies are well-understood study designs that help drug companies generate data to support drug development and registration. Variations from conventional study designs can be required as a result of the specific characteristics of individual drugs or the need for particular data to support drug registration. This poster describes scenarios where alternative study designs and approaches have been required. Download our poster today.

The integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic (PK) study in healthy volunteers was successfully applied to develop an HPMC matrix tablet that achieved the desired PK characteristics for SLx-2101.The key formulation variables influencing performance were the range of dose and release rate, hence a two-dimensional (2D) design space was mapped by manufacturing and characterizing four “regulatory batches” bracketing the corners of the compositional ranges.

Download our poster titled, 'Development and Optimization of MR Formulations in the absence of predictive laboratory or preclinical models' here.

Deutetrabenazine (Austedo, Teva) is approved for the treatment of chorea associated with Huntington’s disease (HD) and tardive dyskinesia (TD). Deutetrabenazine is the first deuterated product approved by the FDA and only the second product approved in HD and TD. Deutetrabenazine is a novel VMAT2 inhibitor that is structurally related to tetrabenazine, with two trideuteromethoxy groups at the 9- and 10-positions in tetrabenazine

Request a copy of our study that compared the Mass Balance Recovery and Metabolite Profile of 14C-Deutetrabenazine and 14C-Tetrabenazine in Healthy Male Subjects.

The aim of the development program was to develop an aqueous, multidose oral liquid formulation of glycopyrronium bromide 2mg/5ml for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in paediatric patients aged 3 years and older with chronic neurological disorders.

Download our poster resource entitled, 'Development of a Palatable Glycopyrronium Bromide Liquid for Pediatrics.'

Download Quotient Sciences' poster on the benefits of spray-drying to address poor drug solubility in early-phase clinical trial research.

Poster features:
 

• 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.