Overcoming Pitfalls and Challenges with Software Validation
As a quality consultant and quality system subject matter expert in the Life Sciences Industry…
CertaraJune 29, 2018
Achieving Compliance with the FDA’s eCTD Mandate
The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance…
CertaraMay 4, 2018
Using M&S to Evaluate Oncology Drug Dosing
There are numerous challenges in developing oncology drugs: (1) they are often very toxic which…
CertaraApril 13, 2018
Using a Pharmacology to Payer Framework to Support Product Development
Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains…
CertaraMarch 16, 2018
The Many Challenges of Narrative Writing
Narratives are an essential part of any programs’ story, but often become cumbersome due to…
CertaraMarch 13, 2018
Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption
The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological…
CertaraMarch 2, 2018
Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions
Analogous to how a geologist surveys the “lay of the land” to determine if oil…
CertaraFebruary 16, 2018
Using PBPK Models to Assess Fetal Drug Exposure
The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting…
CertaraJanuary 19, 2018
Mind the Gap: Best Practices in Clinical Pharmacology Gap Analysis
Do you get anxious about taking tests? Many people do because they want to show…
CertaraMay 25, 2017
Using Pharmacokinetics to Assure Chemical Food Safety
As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes,…
CertaraMay 12, 2017
