Ich safety guidelines

Presented by : Mr. Patel Sameer Ikbal (M.Pharm,sem 1) (Department of Pharmaceutics)

Supervised by Dr.J.I.Dsouza (Principal & HOD)

Guided by: Miss Shalaka Patki (Department of Pharmaceutics)

(Department of Pharmaceutics )

 Objective- comprehensive set of safety guidelines to

uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough- Non-clinical testing strategy for assessing the QT interval prolongation liability

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Pharmaceuticals This document provides circumstances under which it is necessary to undertake carcinogenicity studies on new drugs. Provide risk factors as well as the intended indications and duration of exposure.

Need for Carcinogenicity Studies of

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 Testing for Carcinogenicity of Pharmaceuticals Guidance on the need to carry out carcinogenicity studies

in both mice and rats.

Testing procedures

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 Dose Selection for Carcinogenicity Studies of

Pharmaceuticals Criteria for the selection of the dose to be used in carcinogenicity studies

Provide implications on reducing the pain or discomfort of

the animals at the maximally tolerated dose (MTD).

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 Guidance On Genotoxicity Testing And Data Interpretation For

Pharmaceuticals Intended For Human Use

S2A: Guidance on Regulatory Genotoxicity Tests for

Pharmaceuticals :specific guidance and recommendations for in vitro and in vivo tests and on the evaluation of test results. It includes a glossary of terms related to genotoxicity tests to improve consistency in applications.
S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing

for Pharmaceuticals; the identification of a standard set of assays to be conducted for registration, and the extent of confirmatory experimentation in any particular genotoxicity assay in the standard battery.

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 Note For Guidance On Toxicokinetics:

The Assessment Of Systemic Exposure In Toxicity Studies

Provide guidance on developing test strategies in

toxicokinetics and the need to integrate pharmacokinetics with toxicity testing, in order to aid in the interpretation of the toxicology findings . Promote rational study design development.

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 Pharmacokinetics: Dose Tissue Distribution Studies This study is required when appropriate data cannot be

derived from other sources

Data required-A comprehensive knowledge of the

absorption, distribution, metabolism and elimination of a compound is important for the interpretation of pharmacology and toxicology studies.
useful for designing toxicology and pharmacology studies
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 Duration Of Chronic Toxicity Testing In Animals safety evaluation of a medicinal product for the development of medicinal products with the

exception of those already covered by the ICH Guideline on Safety Studies for Biotechnological Products, e.g., Monoclonal antibodies, recombinant DNA proteins.

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 Detection Of Toxicity To Reproduction in Male

Fertility Guidance on tests for reproductive toxicity. Defines the periods of treatment to be used in animals to better reflect human exposure to medical products. Allow more specific identification of stages at risk

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 Addendum To Ich S6: Preclinical Safety Evaluation Of

Biotechnology-derived Pharmaceuticals

Provide guidance on use of animal models of disease,

determination of when genotoxicity assays and carcinogenicity studies should be performed. The impact of antibody formation on duration of toxicology studies
Clarification on species selection, study design,

immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential.

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 Safety Pharmacology Studies for Human

Pharmaceuticals
addresses the definition, objectives and scope of safety

pharmacology studies
also addresses which studies are needed before initiation of

Phase 1 clinical studies as well as information needed for marketing.

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 The Non-clinical Evaluation Of The Potential For

Delayed Ventricular Repolarization (Qt Interval Prolongation)

Guideline on non-clinical testing strategy for assessing the

potential of a test substance to delay ventricular repolarization.

Includes non-clinical assays and integrated risk

assessments
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 Immunotoxicity Studies for Human Pharmaceuticals Nonclinical testing for immunosuppressant induced by low

molecular weight drugs It applies to new pharmaceuticals, as well as to marketed drug products proposed for different indications changes in this change could result in unaddressed and relevant toxicological issues Also applicable during CT and following approval to market.

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 Nonclinical Evaluation for Anticancer

Pharmaceuticals
Information for pharmaceuticals that are only intended to treat cancer in patients with late stage regardless of the route of administration. Including both small molecule and biotechnology-derived pharmaceuticals. Describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals.

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 Photosafety Evaluation of Pharmaceuticals This new Guideline on photosafety testing will be a

valuable adjunct to the guidance provided in the M3(R2) Guideline.

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