RapidFACT

RapidFACT dramatically speeds up the optimization of drug products for downstream development for all routes of delivery. Our team of experts will assess your molecule and share ideas on the design of your development program. RapidFACT programs have been successfully used for:

  • evaluating solubilization technologies;
  • optimizing modified release systems;
  • changing route of delivery;
  • and developing combination products.

 

Fact sheets

RapidFACT Fact Sheet Modified Release formulation optimization

 

Whitepapers

Accelerating development of enabled formulations for poorly soluble drugs

 

 

 

Scientific posters

New

A pharmacoscintigraphic study of the relationship between tablet erosion and pharmacokinetics of oral semaglutide Site of absorption of an oral formulation of semaglutide Maximising the Potential of Amorphous Spray-Dried Dispersions to Enhance Clinical Bioavailability AAPS 2016 - A Rapid Formulation Development and Clinical Testing Program to Evaluate the Pharmacokinetics of a Novel Enabled Formulation of Abiraterone acetate

 

 

Presentations

AAPS 2016 Symposium - Integrating Formulation Approaches and Regulatory Strategies to Ensure that Adaptive Designs Meet the Needs of Patients, Regulators, and Sponsors

 

Archive

AAPS 2016 - Integrated formulation and clinical programs used to realize the maximum potential of amorphous dispersion-based oral products Novel Gastroretentive Controlled Release Formulations for Once-Daily Administration: Assessment of Clinical Feasibility and Formulation Concept for Raltegravir AAPS 2015 - Rapid Formulation Development and Clinical Testing of Gastro-Retentive Controlled Release Technology to Enable Once-Daily Dosing AAPS 2015 - A Phase I Program to Assess the Pharmacokinetics of a New Salt Form of CO-1686 and Prototype Formulations in Healthy Volunteers CRS 2015 - Utilization of RapidFACT strategies to evaluate and develop an In Vitro -In Vivo Correlation (IVIVC) for Modified Release Formulations of Lorcaserin HCl Rapid formulation development and clinical evaluation of ocular formulations of AMA0076 based upon intra-ocular pressure lowering Application of formulation design space to drive rapid development and clinical optimization of drug products – 5 years of innovation Rapid formulation development and clinical evaluation of enabled formulations of IDX-719 Rapid formulation development and clinical testing (RapidFACT™) strategies in the development of controlled release products CRS 2014 Empowering QbD programs by rapid clinical evaluation of critical-to-performance parameters: an assessment of drug particle size AAPS 2013 Impact of Differences in Regional Bioavailability on IVIVC Development for Modified Release Drug Products AAPS 2013 Development of a Formulation Design Space to Enable Real-Time Optimisation of a Modified Release (MR) tablet Composition within a Flexible Clinical Study APS 2013 Rapid Clinical Screening of a Nanosized poorly Soluble Drug Substance as an Alternative Means to Achieve Extended Release AAPS 2012 Development of a Formulation Design Space to Enable Real-Time Optimisation of a Modified Release (MR) tablet Composition within a Flexible Clinical Study AAPS 2012 Development of a Formulation Design Space to Enable Real-Time Optimisation of a Modified Release (MR) tablet Composition within a Flexible Clinical Study UKTI 2012 Development and clinical testing of lipid based formulations to enhance oral bioavailability of a BCS Class 11 drug ASCPT 2011 Development and clinical testing of lipid based formulations to enhance oral bioavailability of a BCS Class 11 drug AAPS 2011 Validation of rapid formulation development and clinical testing strategies to optimise the development of oral drug products AAPS 2011 Development of a formulation design space for SLx-2101 modified release tablets to enable a flexible phase 1 pharmacokinetic study CRS 2010 Addressing the challenges of poor solubility: Rapid development and clinical evaluation of a lipid based formulation to enhance oral bioavailability of amuvatinib (MP-470) AAPS 2010 Formulation Design Space - Enhancing Flexibility and Precision in the Early Clinical Development of Modified Release Oral Dosage Forms AAPS 2009

 Addressing the challenges of poorly soluble drugs in early development

 Development of a gastric retentive system as a sustained-release formulation of pranlukast hydrate and its subsequent in vivo verification in human studies

 

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Data sciences