§888.3046. Resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial. — Inbound Citations

(v) For the specifications noted in paragraphs (b)(4)(i) through (b)(4)(iv) of this section, a description of the analytical procedures and a summary of the analytical procedures development and validation must be provided. For in vitro elution/drug release specifications, data must be provided to demonstrate method adequacy, e.g., in terms of discriminating power for changes/differences in critical quality attributes that could impact product performance, stability-indicating potential, and/or in vitro-in vivo correlation.

(v) For the specifications noted in paragraphs (b)(4)(i) through (b)(4)(iv) of this section, a description of the analytical procedures and a summary of the analytical procedures development and validation must be provided. For in vitro elution/drug release specifications, data must be provided to demonstrate method adequacy, e.g., in terms of discriminating power for changes/differences in critical quality attributes that could impact product performance, stability-indicating potential, and/or in vitro-in vivo correlation.

(v) For the specifications noted in paragraphs (b)(4)(i) through (b)(4)(iv) of this section, a description of the analytical procedures and a summary of the analytical procedures development and validation must be provided. For in vitro elution/drug release specifications, data must be provided to demonstrate method adequacy, e.g., in terms of discriminating power for changes/differences in critical quality attributes that could impact product performance, stability-indicating potential, and/or in vitro-in vivo correlation.

(v) For the specifications noted in paragraphs (b)(4)(i) through (b)(4)(iv) of this section, a description of the analytical procedures and a summary of the analytical procedures development and validation must be provided. For in vitro elution/drug release specifications, data must be provided to demonstrate method adequacy, e.g., in terms of discriminating power for changes/differences in critical quality attributes that could impact product performance, stability-indicating potential, and/or in vitro-in vivo correlation.