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Related Concept Videos

Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
Cancer02:18

Cancer

Cancers arise due to mutations in genes involved in the regulation of cell division, which leads to unrestricted cell proliferation. Modern science and medicine have made great strides in the understanding and treatment of cancer, including eradicating cancer in some patients. However, there is still no cure for cancer. This is largely due to the fact that cancer is a large group of many diseases.
Treatment Resistent Cancers02:56

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Treatment Resistant Cancers02:56

Treatment Resistant Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Cancer Therapies02:49

Cancer Therapies

Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...

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Updated: May 30, 2026

Through the Looking Glass: Time-lapse Microscopy and Longitudinal Tracking of Single Cells to Study Anti-cancer Therapeutics
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ICH S9: Developing anticancer drugs, one year later.

Rafael Ponce1

  • 1Amgen, Seattle, Washington 98119, USA. rponce@amgen.com

Toxicologic Pathology
|August 24, 2011
PubMed
Summary
This summary is machine-generated.

The International Council for Harmonisation (ICH) S9 guidance aids nonclinical development for advanced cancer therapeutics. This summary discusses ambiguities in patient identification, initial safe dosing, and recovery data requirements for oncology drug development.

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Oncology Drug Development

Background:

  • The International Council for Harmonisation (ICH) S9 provides the first regulatory guidance for nonclinical development of advanced cancer therapeutics.
  • ICH S9 harmonizes regulatory expectations and addresses risk-benefit considerations for expediting oncology drug development.
  • Limited practical application of ICH S9 necessitates further discussion and clarification.

Purpose of the Study:

  • To analyze key areas of ambiguity within the ICH S9 guidance.
  • To facilitate a better understanding and application of ICH S9 for oncology therapeutics.
  • To address challenges in nonclinical development for advanced cancer drugs.

Main Methods:

  • Review and critical analysis of the ICH S9 guidance document.
  • Identification of specific sections requiring further interpretation.
  • Discussion of practical implications for drug development companies and regulatory agencies.

Main Results:

  • Key ambiguities identified in patient population identification for nonclinical studies.
  • Challenges in selecting the initial safe dose for first-in-human trials under ICH S9.
  • Uncertainty regarding nonclinical recovery data requirements.

Conclusions:

  • Clarification of ambiguities in ICH S9 is crucial for effective nonclinical development of oncology therapeutics.
  • Addressing these ambiguities will improve the harmonization of regulatory expectations.
  • Further collective experience and discussion are needed to optimize the application of ICH S9.