A QSP model was built to evaluate its use in drug discovery for complex neurodegenerative diseases, e.g. Alzheimer’s.
A M&S model was built to offer an alternate approach to dedicated timing studies to determine the best time to vaccinate pregnant women.
This blog discusses the development of pharmacokinetic CDISC data standards and the impact of building them for electronic regulatory submissions.
Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. However, this is a challenging process for today’s complex drugs and alternative delivery methods. Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The … Continued
“Come senators, congressmen Please heed the call Don’t stand in the doorway Don’t block up the hall For he that gets hurt Will be he who has stalled” Bob Dylan recorded his iconic “The Times They Are a Changin’” in 1963; the song was released on the 1964 album by the same name. One of … Continued
Model-based Meta-analysis is a framework to compare drugs used to treat diabetic peripheral neuropathy, post-herpetic neuralgia & fibromyalgia.
Natural history studies follow a group of people over time who have or are at risk of developing a specific disease. This type of study is an important tool in modern drug development and in assessing new health technologies by payers. This is especially true for rare diseases or diseases with high, unmet medical need … Continued
High prices for drugs for rare diseases have introduced uncertainties from payers around whether a medication’s value justifies its price.
Model-based meta-analysis is a quantitative framework that uses PK/PD and statistical modeling of external data to inform drug development decisions.
Dr. Mayumi Hasegawa is a clinical pharmacology and pharmacometrics expert who specializes in drug development for the Asia-Pacific regions.