2.3.P Drug Product
2.3.P Drug Product
2.3.P Drug Product
Read the guidance on creating appendices for Module 4 documents. Note that granular templates are recommended if preparing an NDA. Please email info@artosai.com for more information.
Read the guidance on creating appendices for Module 4 documents. Note that granular templates are recommended if preparing an NDA. Please email info@artosai.com for more information.
Read the guidance on creating appendices for Module 4 documents. Note that granular templates are recommended if preparing an NDA. Please email info@artosai.com for more information.
2.3.P.1 Drug Product
2.3.P.1 Drug Product
2.3.P.1 Drug Product
Read the guidance on creating appendices for Module 4 documents.
Read the guidance on creating appendices for Module 4 documents.
Read the guidance on creating appendices for Module 4 documents.
2.3.P.2 Pharmaceutical Development
2.3.P.2 Pharmaceutical Development
2.3.P.2 Pharmaceutical Development
The information and data from section 3.2.P.2 of Module 3 should be discussed. A table summarizing the composition of the formulations used in clinical trials, along with relevant dissolution profiles, should be included as needed.
The information and data from section 3.2.P.2 of Module 3 should be discussed. A table summarizing the composition of the formulations used in clinical trials, along with relevant dissolution profiles, should be included as needed.
The information and data from section 3.2.P.2 of Module 3 should be discussed. A table summarizing the composition of the formulations used in clinical trials, along with relevant dissolution profiles, should be included as needed.
2.3.P.3 Manufacture
2.3.P.3 Manufacture
2.3.P.3 Manufacture
2.3.P.4 Control of Excipients
2.3.P.4 Control of Excipients
2.3.P.4 Control of Excipients
A concise summary of the quality of excipients, as outlined in section 3.2.P.4 of Module 3, should be included.
A concise summary of the quality of excipients, as outlined in section 3.2.P.4 of Module 3, should be included.
A concise summary of the quality of excipients, as outlined in section 3.2.P.4 of Module 3, should be included.
2.3.P.5 Control of Drug Product
2.3.P.5 Control of Drug Product
2.3.P.5 Control of Drug Product
A concise summary of the quality of excipients, as outlined in section 3.2.P.4 of Module 3, should be included.
A concise summary of the quality of excipients, as outlined in section 3.2.P.4 of Module 3, should be included.
A concise summary of the quality of excipients, as outlined in section 3.2.P.4 of Module 3, should be included.
2.3.P.6 Reference Standards or Materials
2.3.P.6 Reference Standards or Materials
2.3.P.6 Reference Standards or Materials
2.3.P.7 Container Closure System
2.3.P.7 Container Closure System
2.3.P.7 Container Closure System
2.3.P.8 Stability
2.3.P.8 Stability
2.3.P.8 Stability
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