sameer ich guidelines

7/31/2019 Sameer ICH Guidelines

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Presented by :

Mr. Patel Sameer Ikbal

(M.Pharm,sem 1)

(Department of Pharmaceutics)

Supervised by

Dr.J.I.Dsouza

(Principal & HOD)

(Department of Pharmaceutics )

Guided by:

Miss Shalaka Patki

(Department of Pharmaceutics)


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Objective- comprehensive set of safety guidelines touncover potential risks like carcinogenicity,genotoxicity and reprotoxicity.

A recent breakthrough- Non-clinical testing strategyfor assessing the QT interval prolongation liability

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This document provides circumstances under which it isnecessary to undertake carcinogenicity studies on new

drugs. Provide risk factors as well as the intended indications and

duration of exposure.



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Testing for Carcinogenicity of Pharmaceuticals

Guidance on the need to carry out carcinogenicity studiesin both mice and rats.

Testing procedures



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Dose Selection for Carcinogenicity Studies ofPharmaceuticals

Criteria for the selection of the dose to be used incarcinogenicity studies

Provide implications on reducing the pain or discomfort ofthe animals at the maximally tolerated dose (MTD).



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Guidance On Genotoxicity Testing And Data Interpretation ForPharmaceuticals Intended For Human Use

S2A: Guidance on Regulatory Genotoxicity Tests forPharmaceuticals :specific guidance and recommendations for in vitroand in vivo tests and on the evaluation of test results.

It includes a glossary of terms related to genotoxicity tests to improveconsistency in applications.

S2B: Genotoxicity: A Standard Battery for Genotoxicity Testingfor Pharmaceuticals; the identification of a standard set of assays to

be conducted for registration, and the extent of confirmatoryexperimentation in any particular genotoxicity assay in the standardbattery.



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Note For Guidance On Toxicokinetics:The Assessment Of Systemic Exposure In ToxicityStudies

Provide guidance on developing test strategies intoxicokinetics and the need to integrate pharmacokinetics

with toxicity testing, in order to aid in the interpretation ofthe toxicology findings .

Promote rational study design development.



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Pharmacokinetics: Dose Tissue Distribution Studies

This study is required when appropriate data cannot bederived from other sources

Data required-A comprehensive knowledge of theabsorption, distribution, metabolism and elimination of acompound 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 theexception of those already covered by the ICH Guideline onSafety Studies for Biotechnological Products, e.g.,

Monoclonal antibodies, recombinant DNA proteins.



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Detection Of Toxicity To Reproduction in MaleFertility

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 OfBiotechnology-derived Pharmaceuticals

Provide guidance on use of animal models of disease,determination of when genotoxicity assays andcarcinogenicity studies should be performed.

The impact of antibody formation on duration oftoxicology studies

Clarification on species selection, study design,immunogenicity, reproductive and developmental toxicityand assessment of carcinogenic potential.



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Safety Pharmacology Studies for HumanPharmaceuticals

addresses the definition, objectives and scope of safetypharmacology studies

also addresses which studies are needed before initiation ofPhase 1 clinical studies as well as information needed formarketing.

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The Non-clinical Evaluation Of The Potential ForDelayed Ventricular Repolarization (Qt IntervalProlongation)

Guideline on non-clinical testing strategy for assessing thepotential of a test substance to delay ventricularrepolarization.

Includes non-clinical assays and integrated riskassessments



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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 changesin this change could result in unaddressed and relevanttoxicological issues

Also applicable during CT and following approval tomarket.



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Photosafety Evaluation of Pharmaceuticals

This new Guideline on photosafety testing will be a

valuable adjunct to the guidanceprovided in the M3(R2)Guideline.



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sameer ich guidelines

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