The progress made over the past 30 years in the international harmonization of safety
testing guidance has provided the basis to inform toxicity testing paradigms. Expectations of …

Since its publication in 1997, the ICH guideline on the Preclinical Safety Evaluation of
Biotechnology-Derived Pharmaceuticals (“ICH S6”) has fostered consistency while …

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria
for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current …

A clear, straightforward resource to guide you through preclinical drug development
Following this book's step-by-step guidance, you can successfully initiate and complete …

Biotechnologically-derived pharmaceuticals possess unique and often species-specific
biological characteristics. Their preclinical safety evaluation therefore presents unusual …

The determination of ''safe use conditions''for the use of new therapeutic agents in clinical
trials is a complex undertaking that involves collaboration among many development …

The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development
is a science-focused organization of pharmaceutical and biotechnology companies. The …

This chapter discusses the main components of nonclinical toxicology evaluation to support
the risk assessment of a clinical candidate and enable human clinical trials. It describes …

There is an active debate in toxicology literature about the utility of animal testing vis-a-vis
alternative in vitro paradigms. To provide a balanced perspective and add to this discourse it …

This chapter examines what is meant generally by “regulatory toxicology” and why we need
it. It explores how drug disasters prompted the origin of this subdiscipline of toxicology, and …