eBook
Next Generation of Small Molecule Oral Drugs
A connected, data-driven approach to managing bioavailability challenges in new chemical entities
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eBook
Pediatric Patient Considerations During Dose Development
Developing specific dosing guidelines and acceptable dosage forms for pediatric patients to optimize therapeutic efficacy and limit and prevent serious adverse side effects.
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eBook
PBPK Modeling and Other Strategies for Early Phase Success
Leveraging knowledge about an API’s physiochemical properties from preformulation and formulation studies increases the chances of early-phase success.
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Webinars
Overcoming Technology Transfer Challenges
The key to a successful tech transfer is for the vendor and the contract manufacturer to anticipate the challenges and come up with a game plan for the solutions to potential challenges.
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eBook
The Importance of Assessing Elemental Impurities
Developing a tailored package of analysis to ensure compliance with regulatory guidelines.
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Webinars
Expanding Your OTC Brand
Innovative dose forms to expand and improve your product line.
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Webinars
Dose Design: Bridging Early- And Late-Phase Development
This webcast discusses key concepts that should be addressed as a molecule advances through the clinical development phases
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Article
Risk Assessment & Test Requirements for Elemental Impurities
Selecting the best risk assessment and analytical testing strategy is key to successful compliance with the new regulations.
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Article
Best Practices for Identifying Development Candidates
The use of Pre-clinical tools to study pharmacokinetics, choose a lead drug candidate and move that product into development.
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Webinars
Phase Appropriate Stability Studies
Regulatory requirements and technical challenges for stability studies vary depending on the phase of the program, the intended market and the product type.
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