Design and Analysis of Bridging Studies
Language: English
Published by CRC Press, 2020
- Softcover
- New
Seller: PBShop.store US, Wood Dale, IL, U.S.A.PBShop.store US
AbeBooks seller since April 7, 2005
Condition: New
£ 72.99
Quantity: Over 20 available
Add to basketItem description from seller
New Book. Shipped from UK. Established seller since 2000.
Seller Inventory # L2-9780367576745
- Title
- Design and Analysis of Bridging Studies
- Publisher
- CRC Press
- Publication year
- 2020
- Condition
- New
- Binding
- PAP
- Language
- English
- ISBN 10
- 0367576740
- ISBN 13
- 9780367576745
- Item weight
- 475 grams
- Series
- Book 28 of 155: Chapman & Hall/CRC Biostatistics
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.
Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region.
Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.
"Synopsis" may belong to another edition of this title.
About the Author
Jen-pei Liu is a professor in the Division of Biometry, Department of Agronomy, and Institute of Epidemiology and Preventative Medicine at National Taiwan University. He is also an adjunct investigator in the Institute of Population Health Sciences at the National Health Research Institutes in Taiwan. A fellow of the ASA, Dr. Liu is an associate editor of the Journal of Biopharmaceutical Statistics and an editor of the Chapman & Hall/CRC Biostatistics Series. He has authored ten books, over 120 peer-reviewed research articles, and over 40 book chapters. His research interests include statistical methodology in bioequivalence evaluation, clinical trials, equivalence and noninferiority testing, bridging testing, statistical quality control in biopharmaceutical products, diagnostic testing, statistical QA/QC for biochip diagnostic products, and evaluation of substantial equivalence in GMO crops and food.
Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke–National University of Singapore Graduate Medical School. He is the editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He has authored or co-authored over 200 papers and 19 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.
Chin-Fu Hsiao is an investigator in the Institute of Population Health Sciences at the National Health Research Institutes in Taiwan. Dr. Hsiao is also an adjunct associate professor at National Chiao Tung University. His research interests encompass Bayesian analysis, clinical trials, and genetic study.
"About the title" may belong to another edition of this title.
PBShop.store US
Wood Dale, IL, U.S.A.
AbeBooks seller since April 7, 2005
Shipping rates within U.S.A.
| Item | 7 to 14 business days | 7 to 14 business days |
|---|---|---|
| First item | £ 0.00 | £ 0.00 |
Payment methods
Store description
We first started out as “The Paperback Exchange,” a chain of physical bookstores where we would part exchange your beloved books for new stories to transport you to faraway places. However, as shopping started to evolve to online shops and marketplaces, we bid our stores goodbye to become “PBShop.” This transition has only allowed us to blossom as we now ship thousands of titles to book lovers across the globe. We pride ourselves in being a community of local book lovers which allows our passion and devotion to shine in everything we do. In 2020 we not only celebrated our 20th birthday but our 1st birthday as being completely employee owned after becoming an E.O.T in September 2019. We are proud to be different and embrace standing apart on a book mountain by working from a virtual inventory which allows us to provide thousands of books that may be difficult to get for your bookshelf or your studies. Working with a number of different suppliers allows us to explore other avenues such as puzzles, sheet music and even stationery so we really do have something for everyone. Life is about being versatile in all realms of existence. If this is your first visit or you are a returning customer, we would like to welcome you to the PBShop family, for there is no friend as loyal as a book. We are a company who put our customers at the centre of everything we do as we understand the importance of reading because once you learn to read, you will forever be free. There are a whole lot of things in this world of ours that we are yet to explore, which is why we will forever inspire curious minds.…
Specialty
Hardbacks, PaperbacksSeller's business information
Pbshop.co.uk Ltd
Unit 22 Horcott Industrial Estate, Horcott Road
Fairford, United Kingdom GL7 4BX
Terms of sale
Returns Policy
We ask all customers to contact us for authorisation should they wish to return their order. Orders returned without authorisation may not be credited.
If you wish to return, please contact us within 14 days of receiving your order to obtain authorisation.
Returns requested beyond this time will not be authorised.
Our team will provide full instructions on how to return your order and once received our returns department will process your refund.
Please note the cost to return any unwanted order to us is borne by the buyer.
Should your order arrive damaged, not as advertised or faulty, we must be advised of this within 14 days of delivery. Please contact us so we can find the best solution for you.
Our Customer Care Team can be contacted via emailing paperback-us@paperbackshop.co.uk, or by calling our UK Office on +441285 712 917. We are available 9:00am till 5:30pm GMT weekdays and 9:00am till 1:00pm GMT on Saturdays.
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to PBShop.store US, Springfield Gardens, New York, U.S.A., +44 1285 712917, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
Books are shipped from our US or UK warehouses. Delivery estimates allow for delivery from either location.