ToxInsights | TigerTox

Is Pharmaceutical Collaboration an Oxymoron?

by cdavenport | Personalized medicine, Pharmaceutical Business

Pharmaceutical companies that share drug development risks and costs are better able to negotiate reimbursement and defend competition, but legal complexity is increased.

Dried Blood Spot Analysis: Preclinical Considerations

by cdavenport | FDA, Preclinical, Techniques

Some preclinical considerations of utilizing dried blood spot analysis/dried matrix spotting include the regulatory ambiguity of validation guidelines, variations due to differential hematocrit, blotter paper standardization, and use with alternate limited-volume body fluids.

Drug Labels: Toxicity or Information Overload?

by cdavenport | Drug Safety, Risk Management, toxicity

Information overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability. Although providing drug safety information more efficiently to both health care providers and the public is warranted, drug manufacturer liability concerns must also be addressed.

Translational Toxicology: Biomarker Development

by cdavenport | Drug Safety, Renal, toxicity

Translational toxicology: a review of the status of both qualification and validation of translational biomarkers.

Drug Abuse Liability Testing

by cdavenport | Abuse Liability, Drug Safety, Safety Pharmacology, TigerU

New drugs that penetrate the central nervous system (CNS) must undergo analysis of abuse liability potential (e.g., behavioral pharmacology, animal drug discrimination, and self-administration data). Multiple variables must be considered.

Turbulent Blood Flow may Increase Cardiovascular Risk

by cdavenport | Cardiovascular, Drug Safety, toxicity

Fluid retention is detrimental for the cardiovascular system because it increases the likelihood that blood will flow in a turbulent manner, regardless of whether or not blood pressure is raised. It may be possible to reduce or neutralize the increased risk by simultaneously administering a diuretic.

FDA Strengthens the Science of Regulatory Safety

by cdavenport | Drug Safety, FDA, Health Care Reform, Postmarket Surveillance, Regulatory

The FDA wants to strengthen both the field and application of regulatory science relative to drug discovery, development, review, and post-market surveillance.

Dried Blood Spot Analysis: Preclinical Pros and Cons

by cdavenport | ADME, EMA, FDA, Techniques

Both advantages and challenges exist for use of dried blood spots during preclinical drug development, and global regulatory acceptance is uncertain.

Personalized Medicine: Friend or Foe?

by cdavenport | Drug Safety, Personalized medicine, Pharmaceutical Business

Personalized medicine is anticipated to enhance drug safety of both new and existing medications, but it may also increase preclinical development costs, limit the potential market, and lower pharmaceutical sales.

FDA Sentinel Initiative: Public / Private Postmarketing Surveillance

by cdavenport | Drug Safety, FDA, Postmarket Surveillance

Through initiation of the Sentinel Initiative (May 2008), the Food and Drug Administration (FDA) is developing the capacity for actively monitoring the safety of approved medical products using the electronic health information in claims systems, inpatient and outpatient medical records, and patient registries.

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