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Stability Testing of Drug Substances and Drug Products 35C.

DRUG PRODUCT • 3-month accelerated stability studies • Long-term stability studies (available data at Original ANDAs should contain stability data generatedunder the long-term and accelerated stability storage con- the time of original filing and subsequentditions delineated in V.

ANDA DATA PACKAGE RECOMMENDATIONS testing through the proposed expiration date) if significant change is seen after 3 months during For simple dosage forms, the following stability data pack- the accelerated stability studies (the tentativeage is recommended: expiration dating period will be determined based on the available data from the additional • Accelerated stability data at 0, 1, 2, and 3 months: studies) A tentative expiration dating period of up to 24 months will be granted based on satisfactory F.

She notes the sexy Geishas, femme fatales and Kung Fu fighting seductresses in place of what she calls “ethnically neutral roles”.Elizabeth Chan, a British Chinese actress, says acting has offered an insight into how society sees Chinese women, calling parts on offer to her “massively stereotypical”."It’s rare to see a Chinese character written that is ‘normal’ or ‘well rounded’," says Chan, naming a set of typical roles that include: hard-working businesswoman; exotic, gentle flower; illegal immigrant selling DVDs or turning to prostitution (someone once actually yelled “selling DVDs?In the book The Asian Mystique (2005) the author Sheridan Prasso traced the “exoticism” of East Asian women as far back as Marco Polo’s travels along the Silk Road in the 1200s, in the literature and art it inspired.The supportiveeral ANDA recommendations: stability data should be clearly identified. STABILITY STUDY ACCEPTANCE products, transdermal patches, and metered-dose inhalers If the results are satisfactory, a tentative expiration dating period of up to 24 months at the labeled storage conditions • Drug products without a significant body of may be granted.Where data from accelerated studies are information used to project a tentative expiration dating period that is beyond a date supported by actual long-term studies on • New dosage forms submitted through the ANDA production batches, the application should include a com- suitability petition process (Q1C applications) mitment to conduct long-term stability studies on the first three production batches and annual batches until the ten- • Other exceptions may exist and should be dis- tative expiration dating period is verified or the appropriate cussed with the Office of Generic Drugs expiration dating period is determined.

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