ICH guideline

ICH S9: Nonclinical Evaluation for Anticancer Pharmaceuticals

ICH guideline · Safety Guidelines · Step 5

Key facts

ICH code S9
Title Nonclinical Evaluation for Anticancer Pharmaceuticals
Guideline series Safety Guidelines
ICH step Step 5
ICH summary (excerpt) The ICH Harmonised Guideline was adopted under Step 4 in October 2009. This Guideline provides information for pharmaceuticals that are intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived…
File S9 Step 4 Presentation
File type PDF
File on ich.org database.ich.org

At a glance

  • No Full text searchable in Orca1
  • S9 Step 4 Presentation Files published by ICH
  • 1–9 FDA guidance documents based on this guideline

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About ICH guidelines

ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.

Source: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline summaries are ICH material, reproduced with acknowledgement

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