PDA Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms (single user digital version)
- Published
- Jan 2018
- ISBN
- 9781945584008
- Pages
- 30
- PDA Item Number
- 43535
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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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.
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary
- Background and Benchmarking
- Product Types and Formulations
- Sources and Mitigation
- Sampling, Testing, and Particle Identification
- Clinical Relevance
- Risk Assessment
- Conclusion
- References
Figures and Tables Index