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Summary: Early clinical trials are becoming more complex as sponsors face rising regulatory requirements and the challenges of developing advanced drug candidates.

Early-phase trials are often delayed by rigid manufacturing models, fixed-dose formats, and limited API availability.

Formulating Beyond Rule of Five (bRo5) molecules presents significant bioavailability and development challenges, especially for small or emerging pharma with limited API and constrained budgets.

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions.

Summary: This article provides an in-depth review of milling equipment, including jet, pin, hammer, conical, and cryogenic mills.

In this webinar, participants will learn about a comprehensive strategy to streamline development and derisk clinical studies. Experts will focus on the importance of physiologically based pharmacokinetic (PBPK) modeling, formulation, and technology expertise while sparing API and managing funding and timeline challenges.

Summary: This executive summary showcases critical considerations and strategies for dosing lipid formulations in preclinical models, along with an overview of the regulatory and technical nuances involved in advancing preclinical lipid-based formulations (LBF) to viable clinical dosage forms.

Summary: In this interview with Pharmtech, Karunakar Sukuru, Global Vice President, Rx Product Development, Pharma and Consumer Health, ºÚÁÏÉç shares his thoughts on the key benefits of Lipid based formulations (LBF.)

Summary: This executive summary showcases examples of real-life tactical and operational decisions involved in the integrated approach to drug development.

Summary: Download this fact sheet to learn more about our experience and expertise with nitrosamines testing.