9780470371381 - guidebook for drug regulatory submissions von weinberg, sandy (9 Ergebnisse)

HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

Zustand: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.

Zustand: New. pp. x + 379 Illus.

Zustand: New. In English.

Zustand: New. The Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. (Pharmaceutical Outsourcing, April 2009)SANDY WEINBERG is the f.

Hardcover. Zustand: Brand New. 1st edition. 392 pages. 9.75x6.50x0.75 inches. In Stock.

Zustand: New. The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission. Num Pages: 380 pages, Illustrations. BIC Classification: MJ; MM; PN. Category: (P) Professional & Vocational. Dimension: 239 x 158 x 21. Weight in Grams: 638. . 2009. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland. …

Buch. Zustand: Neu. Neuware - Destined to become every regulatory director's essential desktop companionrofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.As well, vital information is provided on the most common types of submissions, including:\* Meeting Requests\* Orphan Drug Applications\* Investigatory New Drug Applications (INDAs)\* New Drug Applications (NDAs)\* 505(b)2 NDAs\* Abbreviated New Drug Applications (ANDAs)\* Annual ReportThis reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.Guidebook for Drug Regulatory Submissions is more than a useful guide-it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.…

Zustand: gut. 2009. Guidebook for Drug Regulatory Submissions In englischer Sprache. pages.