Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)
Language: English
Published by Chapman and Hall/CRC, 2013
- Hardcover
- Used
Seller: Salish Sea Books, Bellingham, WA, U.S.A.Salish Sea Books
AbeBooks seller since May 15, 2007
Condition: Used - Very good
£ 61.78
Quantity: 1 available
Add to basketItem description from seller
1439867941 Very Good++; Hardcover; Close to new condition; Covers are still glossy with "straight" edge-corners; Unblemished textblock edges; The endpapers and all text pages are bright and unmarked; Binding is tight with a straight spine; This book will be stored and delivered in a sturdy cardboard box with foam padding; Medium Format (8.5" - 9.75" tall); Aqua and blue covers with title in white lettering; 2013, Chapman and Hall/CRC; 220 pages; "Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)," by Andreas Sashegyi, et al.
Seller Inventory # SKU-U43AB10507297
- Title
- Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)
- Publisher
- Chapman and Hall/CRC
- Publication year
- 2013
- Condition
- Very Good
- Binding
- Hardcover
- Language
- English
- ISBN 10
- 1439867941
- ISBN 13
- 9781439867945
- Series
- Book 40 of 155: Chapman & Hall/CRC Biostatistics
Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment.
The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule’s journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule’s entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety.
Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.
"Synopsis" may belong to another edition of this title.
About the Author
Andreas Sashegyi is a senior research advisor in the biometrics organization at Eli Lilly and Company, where he divides his time between therapeutic compound support and work in the Benefit Risk Advisory Group. Dr. Sashegyi’s research focuses on the integrated analysis of benefits and risks in pharmaceutical research and development. He received a PhD in biostatistics from the University of Waterloo.
James Felli is a research fellow in the area of drug disposition at Eli Lilly and Company. Dr. Felli is a fellow and current president of the Society of Decision Professionals and an active member of the Decision Analysis Society of INFORMS and the Decision Analysis Affinity Group. His research focuses on developing new benefit-harm models and visualizations, modeling and analyzing stochastic multicriteria decision problems, enriching communication between analysts and nonanalysts, and developing new methods of multidimensional data visualization. He received a PhD in industrial engineering and management science from Northwestern University.
Rebecca Noel is a senior research scientist at Eli Lilly and Company. Dr. Noel is the chair of the Drug Information Association working group for benefit-risk assessment and serves on the Centre for Innovation in Regulatory Science’s Task Force on Benefit-Risk Assessment and the Innovative Medicines Initiative. Her research focuses on developing and promoting systematic approaches to benefit-risk assessment. She received a DrPH in international health and epidemiology from the University of Alabama at Birmingham.
"About the title" may belong to another edition of this title.
Salish Sea Books
Bellingham, WA, U.S.A.
AbeBooks seller since May 15, 2007
Shipping rates within U.S.A.
| Item | 5 to 14 business days | 1 to 3 business days |
|---|---|---|
| First item | £ 3.74 | £ 9.72 |
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Thank you for taking an interest in one of our books. Please see the "Shipping Terms" section below for details on our shipping and returns policies. We are a mail-order only bookstore located in Bellingham, WA specializing in modern out-of-print books of all genres. If you are an international customer, we ship internationally by UPS Worldwide Expedited. The average delivery time is 1 to 2 weeks, and each shipment can be fully tracked at www.ups.com. For international shipments, it is important to provide a valid phone number with your order. Most international shipments are delivered within 2 weeks. The only exceptions are when the customer has not provided a valid phone number and there are import duties which UPS needs to collect before making final delivery. In those cases, the package will be held at a nearby UPS Access Point until the customer either picks up the package in person or makes arrangements over the phone with UPS to release the package for final delivery. Our shipping charge only covers international postage. Import duties vary widely by country and are additional. We thoroughly clean all books that we offer for sale and do all basic book-repairs ourselves. Basic repairs include repairing slanted bindings, applying additional glue to hinges that have become excessively loose, hinge-tape repairs for damaged hinges, minor binding split repairs, gluing small tears in exterior of covers, removal (as much as possible) of black marker marks to covers of ex-library books, removal of smaller non-permanent stickers, straightening of minor bowing to covers or spine, and applying jacket protectors to books with torn or fragile jackets or for especially pristine or collectible books. We do not do major binding repairs, and any un-repairable binding splits or general weakness in binding will be noted. Any significant repairs such as a hinge-tape repair will also be noted. These repairs do not usually change the underlying condition grade, but do make the book more presentable. Some books are beyond help and will be listed as "Fair/Acceptable" or "Poor". Our books are graded conservatively with library books never graded above "Good" and used books rarely graded above "Very Good". Below is a list of the condition grades we use, in descending order: New/Fine Like New/Near Fine Very Good++ Very Good+ Very Good Minus Good++ Good+ Good Fair-to-Good Fair/Acceptable Poor Very Poor We try to grade accurately, but condition grades are often subjective, so please consider also any condition notes and book photos (when available) before placing an order. All book photos posted to our listings are actual photos of the book offered for sale and have been taken by us.…
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Salish Sea Books
WA, U.S.A.
Terms of sale
Thank you for taking an interest in one of our books. We are a mail-order only bookstore located in Bellingham, WA specializing in modern out-of-print books of all genres.
If you are an international customer, we ship internationally by UPS Worldwide Expedited. The average delivery time is 1 to 2 weeks, and each shipment can be fully tracked at www.ups.com. For international shipments, it is important to provide a valid phone number with your order. Most international shipments are delivered within 2 weeks. The only exceptions are when the customer has not provided a valid phone number and there are import duties which UPS needs to collect before making final delivery. In those cases, the package will be held at a nearby UPS Access Point until the customer either picks up the package in person or makes arrangements over the phone with UPS to release the package for final delivery. Our shipping charge only covers international postage. Import duties vary widely by country and are additional.
We thoroughly clean all books that we offer for sale and do all basic book-repairs ourselves. Basic repairs include repairing slanted bindings, applying additional glue to hinges that have become excessively loose, hinge-tape repairs for damaged hinges, minor binding split repairs, gluing small tears in exterior of covers, removal (as much as possible) of black marker marks to covers of ex-library books, removal of smaller non-permanent stickers, straightening of minor bowing to covers or spine, and applying jacket protectors to books with torn or fragile jackets or for especially pristine or collectible books.
We do not do major binding repairs, and any un-repairable binding splits or general weakness in binding will be noted. Any significant repairs such as a hinge-tape repair will also be noted. These repairs do not usually change the underlying condition grade, but do make the book more presentable. Some books are beyond help and will be listed as "Fair/Acceptable" or "Poor".
Our books are graded conservatively with library books never graded above "Good" and used books rarely graded above "Very Good". Below is a list of the condition grades we use, in descending order:
New/Fine
Like New/Near Fine
Very Good++
Very Good+
Very Good Minus
Good++
Good+
Good
Fair-to-Good
Fair/Acceptable
Poor
Very Poor
We try to grade accurately, but condition grades are often subjective, so please consider also any condition notes and book photos (when available) before placing an order.
All book photos posted to our listings are actual photos of the book offered for sale and have been taken by us.
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