Annual Meeting of the Japanese Society of Toxicology
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Invited Lecture
Special Lecture
Educational Lecture
  • Yoichi KUREBAYASHI
    Session ID: EL1
    Published: 2018
    Released: August 10, 2018
    CONFERENCE PROCEEDINGS FREE ACCESS
  • Saryu GOEL, Robert DORSAM, Sruthi Tallapragada KING, Melanie MUELLER, ...
    Session ID: EL2
    Published: 2018
    Released: August 10, 2018
    CONFERENCE PROCEEDINGS FREE ACCESS

    Generic drugs have a major public health impact and account for increasing amounts of prescriptions dispensed in the United States. In 2012, the Generic Drug User Fee Amendments (GDUFA) were enacted to enable U.S. Food and Drug Administration's (FDA) to assess industry user fees to bring greater predictability and timeliness to the review of abbreviated new drug applications (ANDAs) in the United States. During this time, a Pharmacology/Toxicology team was formed within FDA’s Office of Generic Drugs (OGD) to review and ensure that generic drugs are as safe as their respective reference listed drug (RLD). A generic drug must have the same safety profile as the RLD but can differ from its RLD with respect to the levels of impurities (organic or elemental), excipients, solvents, and extractables and leachables. OGD has developed several guidelines specific for generic drugs to provide the generic drug industry with pathways to control or justify the safety of impurities in their proposed generic drug product. In addition, principles from various International Conference on Harmonisation (ICH) guidances are used when reviewing the safety of a generic drug formulation. This session will discuss the principles of pharmacology/toxicology review, relevant guidance, and context of use that underpin the safety assessment that is conducted by the Pharmacology/Toxicology team in OGD. The session will include the following presentations:

    Overview and timing of Pharmacology/Toxicology review for generic drugs

    This presentation will give an overview of “why, when, and how” the Pharmacology/Toxicology team conducts reviews of ANDAs. We will discuss key ICH, FDA and generic-specific guidances that serve as a foundation of Pharmacology/Toxicology review. This presentation will also highlight the ways in which a Pharmacology/Toxicology reviewer addresses safety questions in generic drug applications.

    Safety evaluation of organic impurities in generic drugs

    Drug substance and drug product impurities can change the safety profile of a generic drug when compared with its RLD. Applicants must identify, report, control and provide justification for the levels of impurities according to FDA regulations and ICH guidance to ensure that the safety of impurities in generic drugs is properly addressed. This presentation will discuss control and safety evaluation of both genotoxic and non-genotoxic organic impurities.

    Safety review of excipients in generic drugs

    Excipients in generic drugs may differ from the RLD, but the applicant must provide information that supports the safety of their formulation. The safety justification may include reference to levels that are in FDA-approved products (i.e., listed on the Inactive Ingredient Database), providing published literature for excipient safety, and by considering the route and context of use for the intended patient population. This presentation will outline the methods that the Pharmacology/Toxicology team uses to evaluate the safety of excipients for proposed generic drugs.

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  • Toshio TANAKA
    Session ID: EL3-1
    Published: 2018
    Released: August 10, 2018
    CONFERENCE PROCEEDINGS FREE ACCESS
  • Hajime KOJIMA
    Session ID: EL3-2
    Published: 2018
    Released: August 10, 2018
    CONFERENCE PROCEEDINGS FREE ACCESS
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