1 III.B.1. General Considerations
Toxicologysafety pharmacology Studies support the detection of undesirable adverse effects of pharmaceutical or chemical compounds and identify hazards, they describe the type and degree of toxicity and asses the risks, they support management of the risks in humans, when participating in clinical trials or later as patients after market authorization, and analyze the mechanisms behind the alterations; they extrapolate preclinical hazards to humans and finally help to communicate these risks to populations concerned with exposure of that particular substance.
Toxicology should contribute to the safe use of pharmaceutical compounds in humans. It therefore plays a growing role in the development of pharmaceutical/chemical compounds and their acceptability by regulatory agencies or society.
For the safety of pharmaceutical compounds, a great number of in vitro and/or in vivo experiments are being conducted today. Test strategies for toxicological...
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From http://www.emea.eu.int/htms/human/ich/safety/ichfin.htm:
Topic S1A Note for Guidance on the need for Carcinogenicity Studies of Pharmaceuticals
Topic S1B Note for Guidance on Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals
Topic S1C Note for Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceutical
Topic S1C(R) Note for Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addition of a Limited Dose and related Notes
Topic S2A Note for Guidance on Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
Topic S2B Note for Guidance on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
Topic S3A Note for Guidance on Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies
Topic S3B Note for Guidance on PharmacoKinetics: Guidance for Repeated Dose Tissue Distribution Studies
Topic S4A Note for guidance on Duration of Chronic Toxicity Testing in Animals (Rodent and non Rodent Toxicity Testing)
Topic S5A Note for Guidance on Reproductive Toxicology: Detection of Toxicity to Reproduction for Medicinal Products
Topic S5B Note for Guidance on Reproductive Toxicology: Toxicity on Male Fertility
Topic S6 Note for Preclinical Safety Evaluation of Biotechnology-Derived Products
Topic S7A Note for Guidance on Safety Pharmacology Studies for Human Pharmaceuticals
Topic S7B Note for Guidance on Non-Clinical Evaluation of the potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
Topic S8 Immunotoxicity Studies for Human Pharmaceutical
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© 2006 Springer-Verlag Berlin Heidelberg New York
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Bode, G. (2006). International Guidelines for the Development of Pharmaceutical Compounds. In: Vogel, H.G., Hock, F.J., Maas, J., Mayer, D. (eds) Drug Discovery and Evaluation. Springer, Berlin, Heidelberg. https://doi.org/10.1007/3-540-29804-5_41
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