New Drug Approval Process

Richard A. Guarino, Richard Guarino (Herausgeber)

Buch | Hardcover

548 Seiten

2009 | 5th edition
Crc Press Inc (Verlag)
978-1-4200-8849-6 (ISBN)

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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