Results For "fda"

Using Modeling and Simulation to Quantify the PK of an Anti-HIV Drug for Babies Blog Post

As a scientist at Certara and proud Dad to my three kids, pediatric drug development is a topic that is near to my heart. Clearly, children are not just “small…

Hyperlinking: Making the Most of Navigation in eCTD Submissions Blog Post

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information….

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study? Blog Post

A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac Safety Research Consortium has been formed to design a clinical study in healthy subjects demonstrating…

What is GLP (Good Laboratory Practice)? Blog Post

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits...

A Pilot Study Assessing the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration in Healthy Volunteers Blog Post

Diazepam rectal gel (Diastat®) is the only FDA-approved product indicated for acute repetitive seizures. Despite its proven efficacy, most older children and adults object to this route of administration. As…

Intravenous Topiramate: Comparison of Pharmacokinetics and Safety with the Oral Formulation in Healthy Volunteers Blog Post

Although oral topiramate (TPM) products are widely prescribed for migraines and epilepsy, injectable TPM is not available for human use. We have developed a solubilized TPM formulation using a cyclodextrin matrix, captisol…

What is Quantification Anyway? Blog Post

Bioanalytical analysis is a fundamental tool for the pharmacokineticist. The results of a bioanalysis are the source data for all pharmacokinetic work. Thus a clear understanding of the methodologies and…

Modeling and Predicting Drug Pharmacokinetics in Patients with Renal Impairment Blog Post

Current guidance issued by the US FDA to assess the impact of renal impairment on the pharmacokinetics of a drug under development has recently been updated to include evaluation of…

Where Did the 80-125% Bioequivalence Criteria Come From? Blog Post

Most people involved in clinical pharmacokinetics are familiar with the 80-125% criterion. This criterion is used to compare two treatments with the purpose of evaluating if the treatments are bioequivalent....

Generics and Bioequivalence Blog Post

As the debate about health care in the United States continues forward, the term “generic drugs” has become rather commonplace. What are generic drugs? Are they safe to use? Why…