ToxInsights | TigerTox

Potential Academic Contributions to Drug Development

by cdavenport | Drug Safety, FDA, Techniques

The FDA encourages academic researchers to drive changes in the required testing paradigms (nonclinical and clinical) to enable faster, better, and cheaper drug approvals.

Drug Safety: IOM Pharmacovigilance Report

by cdavenport | Drug Safety, FDA, Postmarket Surveillance, Risk Management

An Institute of Medicine (IOM) committee report makes pharmacovigilance recommendations and favors centralization of drug safety data.

Preclinical Offshoring Anticipated to Continue: Survey

by cdavenport | Drug Safety, Pharmaceutical Business, Toxicology

Preclinical offshoring is anticipated to continue for 2-5 years for early Discovery and non-GLP Toxicology studies, despite narrowing price differentials.

High-throughput ADME Screening Technologies

by cdavenport | ADME, Drug Safety, Regulatory

New methods in high throughput absorption, distribution, metabolism, and excretion screening technology (HT-ADME) are discussed relative to pharmaceutical safety and toxicology.

Drug Safety: Global Regulatory Authorities Encouraged to Share Inspection Results

by cdavenport | Drug Safety, Regulatory

Global regulatory authorities are encouraged to mutually recognize inspection results, which would eliminate the wasteful duplication of effort and enhance drug safety.

Nonclinical Toxicology: FDA Guidance Agenda for 2012

by cdavenport | Drug Safety, FDA, Preclinical, Regulatory

The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012. The proposed nonclinical safety documents are highlighted.

Nonclinical Toxicology Sector Predictions for 2012

by cdavenport | Drug Safety, Pharmaceutical Business, Preclinical, Toxicology

The preclinical toxicology sector is not merely going through a prolonged cyclical slowdown, but has also structurally changed. Growth of this sector in 2012 is expected to be weak; new business models are evolving.

FDA Pre-IND Meetings: Why, When and How

by cdavenport | FDA, Regulatory, TigerU

Introduction to U.S. FDA pre-IND meetings ─ why and when a Sponsor should consider having a meeting and how the Sponsor approaches the process.

FDA Changes Expected with PDUFA V

by cdavenport | FDA, Regulatory

The implications and timing of the new PDUFA V mandates on the drug development are discussed.

Nonclinical Cardiotoxicity Testing: Stem Cell Use

by cdavenport | Cardiovascular, Drug Safety, Techniques

In addition to ion channel testing (e.g., hERG), use of stem-cell-derived cardiac myocytes allows assessment of other functions critical to cardiac cell health.

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