Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline

The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public consultation phase. This guideline has several objectives. While aiming to harmonize methodologies and approaches for pediatric extrapolation in drug development, it balances access to pediatric indications and reduction of children’s exposure to experimental medications where warranted. The ICH E11A webpage outlines these … Continued

A Day in the Life of a Scientific and Medical Publications Professional

Have you ever considered if your drug development program would benefit from partnering with experts in scientific and medical communications and publications? Maybe, we should first address what exactly scientific and medical communications and publishing entails. As medical writers with decades of experience, we can say that every day holds unique, intellectually rigorous challenges. We … Continued

The Utility of Model-Informed Drug Development for Rare Diseases

Model-informed drug development (MIDD) is a network of closely integrated ecosystems that can seamlessly position a new drug candidate while minimizing uncertainty in technical and regulatory success. Indeed, MIDD affords rational scientific hypothesis testing while enabling the clinical development program using strategic pillars. These strategic pillars form a core component of an innovation ecosystem (Figure … Continued

Simulating Realistic Virtual Bioequivalence using Simcyp Simulator: Estimating Within-subject Patient Variability

While using physiologically-based pharmacokinetic modeling (PBPK) in determining virtual bioequivalence (VBE) has significantly increased over the past few years, this type of mechanistic biosimulation still offers enormous potential to supplant expensive and time-consuming clinical studies. The paper referenced below addresses our increased knowledge of oral drug absorption and the applicability of the Simcyp Simulator to … Continued

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

The new Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC), Guidance for Industry, was issued by the US Food and Drug Administration (FDA) in February 2022. ADCs are targeted therapies that are designed to deliver cytotoxic payloads to cancer cells. The cytotoxic payload is attached to a monoclonal antibody (that is designed for binding to the … Continued

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