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| | Guidance for Industry BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, ... (Site not responding. Last check: 2007-10-22) |
 | | When equivalence cannot be demonstrated, applicants should submit a prior approval supplement and should consider appropriate tests for qualification of impurities, demonstration of bioequivalence, and assessment of stability. |
 | | If equivalence cannot be demonstrated on the production batch, this would be considered evidence of an adverse effect on the identity, strength, quality, purity, and/or potency of the drug product, and the change should not be implemented (i.e., the drug product affected by the change should not be distributed). |
 | | When equivalence is not established, applicants should consider conducting an assessment of the effect of the change on the safety and effectiveness of the drug product (e.g., qualification of impurities, bioequivalence studies). |
| www.fda.gov /cder/guidance/3629fnl.htm (7082 words) |
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