ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals

What it says

S9 provides guidance on the nonclinical studies needed to support the clinical development of anticancer pharmaceuticals intended to treat patients with advanced cancer. It describes a streamlined approach to nonclinical safety, pharmacology, toxicology, and timing of studies relative to clinical trials, reflecting the seriousness of the disease and the often cytotoxic nature of the drugs.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Because patients have limited options, development can proceed with a more targeted package than for other medicines.
• Toxicity is expected for many cytotoxic drugs, so the studies focus on defining and monitoring it.
• Some studies, such as certain reproductive toxicity studies, may be done later in development.

What inspectors look for

• Whether nonclinical studies support the clinical dose and schedule.
• Whether studies were conducted under GLP.
• Whether toxicities seen were taken into account in the clinical protocol.

Related regulations