New Drug Approval Process
Redigert av Richard A. Guarino, Richard Guarino, 2009.Del av serien Drugs and the Pharmaceutical Sciences.
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
Updated chapters include:
- advances in international regulatory requirements, including ICH guidelines and harmonization
- a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
- the latest regulatory requirements for expediting new drug approvals
- strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development
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Midlertidig tomt på lager
Bestillingsvare. Forventes sendt om ca 10 dager
Oppdag mer
New Drug Approval Process
Redigert av Richard A. Guarino, Richard Guarino, 2009.Del av serien Drugs and the Pharmaceutical Sciences.
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
Updated chapters include:
- advances in international regulatory requirements, including ICH guidelines and harmonization
- a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
- the latest regulatory requirements for expediting new drug approvals
- strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development
Oppdag mer
Ikke tilgjengelig for Klikk&Hent
Midlertidig tomt på lager
Bestillingsvare. Forventes sendt om ca 10 dager
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