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New Drug Approval Process -

New Drug Approval Process

Buch | Hardcover
548 Seiten
2009 | 5th edition
Crc Press Inc (Verlag)
978-1-4200-8849-6 (ISBN)
CHF 319,95 inkl. MwSt
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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

Richard A. Guarino, Richard Guarino

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.

Erscheint lt. Verlag 24.6.2009
Reihe/Serie Drugs and the Pharmaceutical Sciences
Zusatzinfo 80 Illustrations, black and white
Verlagsort Bosa Roca
Sprache englisch
Maße 152 x 229 mm
Gewicht 1170 g
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Medizin / Pharmazie Pflege
Naturwissenschaften Biologie
Technik
ISBN-10 1-4200-8849-1 / 1420088491
ISBN-13 978-1-4200-8849-6 / 9781420088496
Zustand Neuware
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