International Journal of Drug Development
Table of Contents
Edition 01 - Highlights
Nefazodone CMC Review - Comprehensive
Review of the Chemistry Manufacturing and Controls Key ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
Edition 02 - Highlights
Pentoxifylline ER CMC Review
- Comprehensive Review of the Chemistry Manufacturing and Controls Key
ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
Edition 03 - Highlights
Bupropion CMC Review - Comprehensive
Review of the Chemistry Manufacturing and Controls Key ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
Edition 04 - Highlights
Ticlopidine CMC Review - Comprehensive
Review of the Chemistry Manufacturing and Controls Key ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
Edition 05 - Highlights
Chew Tabs CMC Review - Comprehensive
Review of the Chemistry Manufacturing and Controls Key ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
Edition 06 - Highlights
Modified Release CMC Review
- Comprehensive Review of the Chemistry Manufacturing and Controls Key
ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
Edition 07 - Highlights
Sterile Ophthalmic CMC Review
- Comprehensive Review of the Chemistry Manufacturing and Controls Key
ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
Edition 08 - Highlights
Paclitaxil CMC Review - Comprehensive
Review of the Chemistry Manufacturing and Controls Key ANDA/NDA
New Assay of the Month / Spotlight on Drug Development.
Development S0P of the Month and New FDA Guideline Review
Drug Process Validation Protocol - Flowcharts and Tables
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