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Maximizing Oligonucleotide Therapeutic Development: How They Work

This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest in oligonucleotide therapies, which are composed of short strands of DNA or RNA, is growing rapidly; there are at least 135 of them currently in development.1 Underscoring their proliferation, a PubMed search for “oligonucleotide therapeutics” generated more than 35,000 hits. … Continued

The Model-informed Precision Dosing Revolution Is Coming

Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global regulatory agencies. However, its implementation in clinical care has been modest to date. Model-based approaches are essential to realize the goal of precision dosing—providing the right drug dose to maximize therapeutic benefit, while reducing risk for each individual patient. The … Continued

How PBTK Models Support Toxicological Triage

Did you know that only a small fraction of the tens of thousands of commercially-used chemicals have undergone toxicological assessment? Time and cost constraints, not to mention the ethical impossibility of studying these chemicals in human trials, hamper large-scale toxicological assessment. Physiologically-based toxicokinetic (PBTK) models can be leveraged to predict TK from in vitro measurements … Continued

Effective Communication for Pharmacometricians with Joga Gobburu

The modeling and simulation revolution is transforming our approach to drug development. Quantitative pharmacology models can yield valuable insights that help sponsors make better decisions regarding their drug programs. For pharmacometricians to influence decision making, they must be able to effectively communicate. Dr. Joga Gobburu is a Professor at the University of Maryland Schools of … Continued

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation of a mechanistic understanding of pharmacokinetics since the 1960s. So you might think that he’d be ready for quieter pursuits. But this professor emeritus at the University of Manchester has no plans to stop actively teaching and guiding the pharmaceutical industry’s … Continued

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