Analysis and critical review of ICH Q8, Q9 and Q10 from a generic pharmaceutical industry view point
Generic industry aims to produce safe, efficient, built-in quality medicines that will satisfy patients’ requirements and will be competitive on the market. In this paper, assessment of the need for quality by design (QbD) and process analytical technology (PAT) implementation by generic industry wa...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
2012-01-01
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| Series: | Makedonsko Farmacevtski Bilten |
| Online Access: | http://bulletin.mfd.org.mk/volumes/Volume%2057/57_010.pdf |