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A connected, data-driven approach to managing bioavailability challenges in new chemical entities

Developing specific dosing guidelines and acceptable dosage forms for pediatric patients to optimize therapeutic efficacy and limit and prevent serious adverse side effects.

Leveraging knowledge about an API’s physiochemical properties from preformulation and formulation studies increases the chances of early-phase success.

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.

Developing a tailored package of analysis to ensure compliance with regulatory guidelines.

Innovative dose forms to expand and improve your product line.

This webcast discusses key concepts that should be addressed as a molecule advances through the clinical development phases

Selecting the best risk assessment and analytical testing strategy is key to successful compliance with the new regulations.

The use of Pre-clinical tools to study pharmacokinetics, choose a lead drug candidate and move that product into development.

Regulatory requirements and technical challenges for stability studies vary depending on the phase of the program, the intended market and the product type.