Source:  Toronto Star,  6 March 2015

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Source:  Drug Development News

The post Brain Maps: Live 3D Imaging of Activity appeared first on TigerTox.

Source:  Science Codex

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Pharmacology/Toxicology

• Endocrine Disruption Potential of Drugs: Non Clinical Evaluation

Procedural
• Integrated Summary of Safety

Biopharmaceutics

• Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications General Consideration

Electronic Submissions
• Providing Regulatory Submissions in Electronic Format – General Considerations
• Providing Regulatory Submissions in Electronic Format – Study Data
• Providing Regulatory Submissions in Electronic Format – Standardized Study Data

Source:  U.S. Food and Drug Administration

The post CDER Guidances for Nonclinical Toxicology to Issue in 2012 appeared first on TigerTox.

Source:  Mayo Clinic Proceedings  – pdf of full article.

The post Off-label Drug Use: Fact vs. Fiction appeared first on TigerTox.

Typical applications in pharmaceutical, biotechnology, and healthcare include:
•    Mapping gene-disease relationships and identifying potentially novel therapeutic targets
•    Biomarker discovery
•    Drug repurposing
•    Drug safety
•    Patent analysis
•    Clinical trial site selection and study design
•    Mining electronic medical records to improve prediction of health outcomes
•    Translational medicine
•    Competitive intelligence
•    Social media mining
•    Subjective data mining (sentiment analysis, key opinion mining)

Sources:  BioSpace and Business Weekly

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• Greater knowledge of safety biomarkers improved mechanistic understanding and helped to determine the relevance of nonclinical findings for clinical risk assessment.

• Preclinical inclusion of systems or pathway modeling was deemed important for the selection and interpretation of biomarkers of organ toxicity.

• Physical chemical prediction software or other forms of genetic or developmental and reproductive toxicity (DART) prediction software (e.g., DEREK, M-CASE, Leadscope) were being incorporated into early preclinical development by most companies.  All 3 software companies have Cooperative Research and Development Agreements (CRADA) with the FDA.

• For cellular parameter screens, most companies are using image-based multi-parametric approaches of cellular analysis and cytotoxicity at the single-cell and subcellular level (via High Content Analysis [HCA])

• Off-target screening (usually a CEREP panel) was performed by most companies early in preclinical development.

As might be expected to “slow the burn,” smaller companies ran fewer preclinical screens to predict drug safety and  performed these screens later in the drug development process.  Given that larger companies expect to have this information sooner than later, companies wanting to partner and/or be acquired may consider including more screens for drug safety earlier in their preclinical development programs.

Source:  DSEC Drug Safety Executive Blog

The post Assessing Safety Earlier in Drug Development appeared first on TigerTox.

The Procedure Cage attaches directly to an animal’s home cage allowing animals to enter on their own.  This innovation significantly reduces animal stress by eliminating the need for capture-by-hand or use of other restraints, creating a calmer handling environment.  In addition, the use of this separate cage for study-related procedures allows the animal to always view their home cage as a “safe place.”

The Procedure Cage is currently being tested at six beta test sites including key pharmaceutical industry, government, and university locations.  The results will be presented at the American Association for Laboratory Animal Science (AALAS) National Meeting in Minneapolis on November 4-8, 2012.  The Procedure Cage is available exclusively through SNBL USA.

Procedure Cage Demo:  Click here

Source:  SNBL USA newsletter (18 July 2012)

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This slide presentation gives excellent perspective of past and future trends for the global pharmaceutical market, with emphasis on FDA approvals of NME.

Source Slide Show (pdf hyperlink):  FDA

The post FDA New Drug Reviews: Past and Future Perspectives appeared first on TigerTox.

• Drug exposure and clinical response variability
• Risk for adverse events
• Genotype-specific dosing
• Mechanisms of drug action
• Polymorphic drug target and disposition genes

This resource table lists FDA-approved drugs with pharmacogenomic information / biomarkers in their labels.

Source:  FDA

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