Richard A. Guarino,
Richard Guarino
New Drug Approval Process
Gebonden Engels 2009 5e druk 9781420088496Levertijd ± 11 werkdagen
Gratis verzonden
Samenvatting
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
Specificaties
ISBN13:9781420088496
Taal:Engels
Bindwijze:Gebonden
Aantal pagina's:548
Uitgever:CRC Press
Druk:5
Hoofdrubriek:Geneeskunde, Non-profit
Lezersrecensies
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Inhoudsopgave
Administrative Guidelines for New Product Development. Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval. Developing Clinical Research Trials. Global Regulations for Good Clinical Practices (GCP). Specific Areas of New Product Submissions.
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