Advancing Drugs

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Expert PhD, DABT Toxicologists
Our team is with you every step of the way.  navigating the landscape of Preclinical Services. 

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GLP toxicology studies


An Investigational New Drug (IND) safety and toxicology program can be a challenging undertaking.  Designing a study program with the proper set of GLP toxicology studies to meet FDA requirements is only the beginning of what is needed to be successful.  A well contemplated strategy that includes anticipating issues that may occur based on your type of molecule and its formulation is imperative to minimizing delays and the need for additional studies.   Additionally, understanding when and how to communication with the FDA prior starting your GLP toxicology studies is crucial.


We have been involved with the design, optimization and execution of over 30 IND-enabling programs including the design of GLP toxicology studies and assisting with the preparation for, and the support during, your pre-IND meeting with the FDA.  We routinely minimize issues and save time & costs.





Preclinical CRO Services / toxicology Studies include:


Late-Stage Discovery Studies

Pharmacokinetics Study (PK)

Maximum Tolerated Dose Studies (MTD)

Dose Range Finding Study

hERG - Ion Channel Screening

Exploratory Toxicology Study (7-day non-GLP studies with PK)


GLP Toxicology Studies

7-day Repeat Dose Study (GLP)

14-day Repeat Dose Study (GLP)

21-day Repeat Dose Study (GLP) 

3-month Chronic Repeat Dose Study (GLP)

6-month Chronic Repeat Dose Study (GLP)

9-month Chronic Repeat Dose Study (GLP)

Carcinogenicity Studies (Transgenic & 2 year)


Safety Pharmacology Studies (GLP)

Cardiovascular Study (Telemetry or Piggy-backed)

Respiratory Study

Central Nervous System Study (CNS Study)


Genetic Toxicology (Genetox)

Ames Assay (non-GLP & GLP)

Micronucleus Assay

Chromosomal Aberration Assay


Notes:

All typical drug development rodent and non-rodent species offered

All typical routines of administration offered (including infusion)