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The pharmaceutical industry remains focused on accelerating all aspects of drug discovery and development.
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Careful selection of the right CDMO can make the difference between product success and failure, reducing time, risk, cost and project complexity. Explore selected content from Lonza Small Molecules that will help you identify a partner with exponential progress.
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On Demand Webinar: Improving Solubility and Accelerating Drug Development
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Molecules with solubility challenges continue to dominate drug development pipelines, increasing the demand for formulation technologies that can solve these issues. Join CMC Consultant Peter Timmins, Lonza Senior Research Fellow David Lyon, and Quotient Sciences’ CSO, Peter Scholes, as they outline how a variety of data-driven strategies and integrated program designs can simplify development processes and reduce costs.
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SimpliFiH® Solutions for Accelerated Pharmaceutical Development
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SimpliFiH® Solutions centers on a rapid technology selection methodology that requires a single gram of API to identify a phase I appropriate approach to address:
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- poor bioavailability and solubility
- particle size reduction
- spray dried dispersion (SDD) technology
- liquid/lipid based technology.
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Eliminating parallel technology evaluations saves precious API and time in reaching phase I clinical trials.
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Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Product Development
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Micro-dosing for PIC evaluations is a key component of our early stage product development offering aimed at accelerated feasibility and first-in-human (FIH) studies. Precision micro-dosing is an increasingly effective tool given the trend towards highly potent compounds requiring very small and precise dose levels.
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Benefits achieved in using Xcelodose®-based PIC/PIB studies for early phase studies include:
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- Streamlined product development and reduced costs
- Minimizes drug substance requirements
- Eliminates excipient compatibility screening
- Simplifies analytical and stability evaluations
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Lonza Small Molecules SimpliFiH® Solutions
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With the pharmaceutical industry’s focus on accelerating all aspects of drug discovery and development, it is increasingly critical to reduce the timeline from initial idea to first-in-human (FIH) clinical verification. Aligning with a single, integrated and proven service partner can reduce timelines, as well as reduce the complexity, risks and costs associated with engaging multiple partners.
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We have designed an integrated package to address these challenges and simplify the pathway to first-in-human verification.
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