PDA Technical Report No. 78, Particulate Matter in Oral Dosage Forms documents the current practices used by manufacturers of drug products, active pharmaceutical ingredients, excipients, and packaging/primary containers to control, inspect, sample, and test intrinsic and extrinsic particulate matter in oral dosage forms. The scope of this Technical Report includes current practices of monitoring for particulates, as well as recent quality, clinical relevance, and regulatory experience in oral dosage forms.
Document identifier
PDA TR 78
Title
Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms
Publication date
2018-01-01
International Relationship
| Price |
325 vnd |
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