Ich safety guidelines
Presented by : Mr. Patel Sameer Ikbal ([Link],sem 1) (Department of Pharmaceutics)
Supervised by [Link] (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
TKCP WARANANAGAR
2/17
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
TKCP WARANANAGAR
3/17
Testing for Carcinogenicity of Pharmaceuticals Guidance on the need to carry out carcinogenicity studies
in both mice and rats.
Testing procedures
TKCP WARANANAGAR
4/17
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).
TKCP WARANANAGAR
5/17
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.
TKCP WARANANAGAR
6/17
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.
TKCP WARANANAGAR
7/17
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
TKCP WARANANAGAR
8/17
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.
TKCP WARANANAGAR
9/17
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
TKCP WARANANAGAR
10/17
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.
TKCP WARANANAGAR
11/17
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.
TKCP WARANANAGAR
1217
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
13/17
TKCP WARANANAGAR
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.
TKCP WARANANAGAR
14/17
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.
TKCP WARANANAGAR
15/17
Photosafety Evaluation of Pharmaceuticals This new Guideline on photosafety testing will be a
valuable adjunct to the guidance provided in the M3(R2) Guideline.
TKCP WARANANAGAR
16/17
TKCP WARANANAGAR
17/17
