New Drug Approval Process

AvRichard A. Guarino,Richard Guarino

E-bok

PDF, Engelska, 2016

Del i serien Drugs and the Pharmaceutical Sciences

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Beskrivning

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 harmonizationa step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAsthe latest regulatory requirements for expediting new drug approvalsstrategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development.

Produktinformation

Utgivningsdatum:2016-04-19
Språk:Engelska
Filformat:PDF
Kopieringsskydd:LCP
ISBN:9781420088502
Förlag:Taylor & Francis Inc
Upplaga:5
Serie:Drugs and the Pharmaceutical Sciences

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Richard A. Guarino, Richard Guarino

Innehållsförteckning

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.