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Rationalized Approach to Chemistry, Manufacturing & Control (CMC) Requirements for Orally Inhaled and Nasal Drug Products (OINDPs) Based on Risk Management

Horhota ST, Berger RL, Butterworth N, Chambers DC, Davidson BS, Grant AC, Kaerger J, Leiner S, Lyapustina S, Patel R, Purrington AM.

RDD Europe 2009. Volume 2, 2009: 319-322.

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