12 / 64 resources displayed
-
Scientific Posters
Creating Acceptable Tablets (CAT) -A feasibility study to assess the swallowability and acceptability of different sized placebo tablets in children and young people: an interim analysis
The administration of medicines to children and young people (CYP) poses a challenge to many parents and health care professionals; this is linked to the limited information available for age-appropriate oral formulations.
-
Scientific Posters
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.
-
Scientific Posters
Development of a Palatable Glycopyrronium Bromide Liquid for Paediatrics
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.
-
Webinar
Pediatric Drug Development: Unique Considerations and Challenges
This webinar will explore product considerations when designing pediatric pharmaceutical products, clinical and operational considerations when executing and designing clinical trials for pediatric patient populations and regulatory considerations for pediatric drug development including US and EMEA incentives, guidance and requirements.
-
Scientific Posters
An Open-label, Two-period Study Designed to Evaluate and Compare the Mass Balance Recovery and Metabolite Profile of 14C-Deutetrabenazine and 14C-Tetrabenazine in Healthy Male Subjects
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
-
Webinar
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.
-
Scientific Posters
Development and optimization of MR formulations in the absence of predictive laboratory or preclinical models
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.
-
Scientific Posters
Application Of Non Standard Approaches To Investigations Of Human Mass Balance And Metabolite Characterisation
Conventional human metabolism studies are well understood study designs which 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.
-
Fact Sheet
Translational Pharmaceutics
Translational Pharmaceutics innovates the way you design and implement your drug development program and is proven to reduce drug development costs and shorten timelines.
-
Webinar
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.
-
Scientific Posters
An Evaluation of the Pharmacodynamics, Safety, and Tolerability of the Potassium Binder RDX7675
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.
-
Fact Sheet
Formulation Development
From preclinical and first-in-human (FIH) dosage forms to optimization of your drug products for late stage development, we work with you to develop the most appropriate formulation.