FDA Pre-IND Meetings: Why, When and How

The pre-IND phase of drug development is the foundation upon which all development-related activities (including registration) depend.  It is, therefore, essential to give proper forethought and attention to this initial, all-important step of the drug-development...

Adverse Preclinical Events – Now What?

Drug development is a complicated, often convoluted process.  The ability to predict drug toxicity in humans from nonclinical data remains a major challenge.  Since you can’t “erase” an adverse event, optimization of preclinical dose selection is...

Drug Abuse Liability Testing

Any new drug that penetrates the central nervous system must receive some preclinical analysis of abuse liability potential (Draft Guidance).  Usually, it is determined through prior knowledge of chemistry and/or pharmacology of the candidate’s drug class that...

Genetic Toxicology: Historical and Current Perspectives

Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010 View more presentations from TigerTox. Historical Overview During the past 30 years, genetic toxicology testing has evolved technologically to play an important safety assessment role in the...