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

FDA Project Optimus from a Medical Writing Submission Lead Perspective

At Certara, we work across a spectrum of therapeutic areas, and, as Regulatory and Medical Writing specialists, we are used to seeing the evaluation of drug doses in early-phase, dose-ranging clinical studies. These studies ultimately enable those of us working on regulatory submissions to get the required understanding of dose-response and exposure-response (ER) relationships and … Continued

New Hybrid Engagement Models for Medical Affairs & Medical Communications Teams

Medical affairs and medical communications teams at biopharma companies have traditionally relied on face-to-face interactions to engage key stakeholders. With physicians and other health care providers (HCPs) providing less time for in-person interactions and wanting more non-promotional scientific content, Medical Affairs and Communications teams must rethink their approach as the industry becomes more digitally driven … Continued

5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses

Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and rising costs. Each step of drug development must therefore be as accurate and efficient as possible. In the preclinical phase, the study of pharmacokinetics (PK) and pharmacodynamics (PD) of a new drug plays a crucial role. Regulatory agencies will not … Continued

Enabling Successful US Submissions for Chinese Biotech Companies

Domestic selling constraints on their products are prompting Chinese pharmaceutical companies to seek success abroad. For Chinese companies looking to submit applications to the United States (US) this year, thinking about how and where to start in the publishing and submissions process is daunting. For Chinese BioPharma, the goal is to file to both the … Continued

How to Fix Your Biggest Bioequivalence Mistakes

Bioequivalence is a commonly misunderstood term within biopharmaceutics. For starters, bioequivalence is a technical term baked in regulation. The Code of Federal Regulations (CFR) Subchapter D deals with drugs for human use, and 320.1 contains the key definitions regarding this subject. These are captured in full as follows: § 320.1 Definitions. Bioavailability is defined in … Continued

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