Regulatory Articles

  1. Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

    Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

  2. Two Steps Forward, One Step Back: IND Submission In Early Development

    A panel of product development experts examines blind spots that can plague early development strategies, as well as important considerations when navigating the path toward an IND submission.

  3. Overcome Complex Protein Challenges With Optimized Expression

    Realizing the potential of next-generation molecules calls on appropriate expression technologies and development processes that can facilitate their path to market.