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You think you see your boyfriend in the background talking to a girl.So let them follow a slutty girl and get some eye candy - it doesn't mean anything.ANDAs withdrawn before publication of this guid-ance should not normally have to include stability data in When significant decomposition during storage can-conformance with the guidance on resubmission if the not be prevented, the clinical trial batch of drug productoriginal application was withdrawn because of non–stability- should be retested before the initiation of the trial, andrelated issues.However, if new stability studies are con- information should be submitted to show that it willducted to support the submission, such studies should be remain stable during the course of the trial.This informa-conducted as recommended in the guidance.tion should be based on the limited stability data available when the trial starts. STABILITY TESTING FOR age may be qualified by reference to prior human or ani- INVESTIGATIONAL NDAs mal data.However, in the absence of full-term • Long-term stability data (available data at the stability data for the drug product, adequate accelerated time of original filing and subsequent amend- stability data combined with available long-term data can ments) be used as the basis for granting a tentative expiration dating period.The batch or batches used for stability test- • A minimum of one batch; pilot scale ing should comply fully with the proposed specifications • Additional stability studies (12 months at the for the product and be packaged in the market package, and the release assay should be within reasonable variation intermediate conditions or long-term data (taking into account inherent assay variability) from the through the proposed expiration date) if signif- labeled strength or theoretical strength of the reference- icant change is seen after 3 months during the listed drug.

basis of the available data from the additional study Other supportive stability data may be submitted on drug product batches that may or may not meet the above E. Data on relevant research batches, investigational RECOMMENDATIONS formulations, or alternate container and closure systems, or from other related studies, may also be submitted to The following may be considered exceptions to the gen- support the stability of the drug product.Don't even try to kid yourself, you know damn well you are guilty of all of the above at some degree or another.She notes the sexy Geishas, femme fatales and Kung Fu fighting seductresses in place of what she calls “ethnically neutral roles”.In the BBC’s official response to BEA’s letter, it stated its commitments to diversity (in a rather patronising, verbose manner).But Asian women are understandably in a rush to change the status quo.

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