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The examination of extractable and leachable substances (such as plasticizers, antioxidants, stabilizers and dyes) is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. When there is a change

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AMRI

Anacipher

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INDIA

UNITED STATES

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Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

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AMRI offers toxicological risk assessment (TRA) services to evaluate risks to patient health by assessing the leachates of a system against information on in vitro tests, animal studies, computational methods and predictive means.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Toxicological Risk Assessment (TRA)

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- Service Details

Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria

- Directory Listing

Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Toxicological Risk Assessment (TRA)

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