Real-World Evidence in Drug Development and Evaluation
Language: English
Published by Taylor and Francis Ltd, GB, 2022
- Softcover
- New
Seller: Rarewaves.com USA, London, London, United KingdomRarewaves.com USA
AbeBooks seller since June 11, 2025
Condition: New
£ 76.77
Quantity: Over 20 available
Add to basketItem description from seller
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field.Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions.FeaturesProvides the first book and a single source of information on RWE in drug developmentCovers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD)Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insightsOffers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise.…
Seller Inventory # LU-9780367637019
- Title
- Real-World Evidence in Drug Development and Evaluation
- Author
- Harry Yang
- Publisher
- Taylor and Francis Ltd, GB
- Publication year
- 2022
- Condition
- New
- Binding
- Paperback
- Language
- English
- ISBN 10
- 0367637014
- ISBN 13
- 9780367637019
- Item weight
- 349 grams
- Series
- Book 115 of 155: Chapman & Hall/CRC Biostatistics
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field.
Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions.
Features
- Provides the first book and a single source of information on RWE in drug development
- Covers a broad array of topics on outcomes- and value-based RWE assessments
- Demonstrates proper Bayesian application and causal inference for real-world data (RWD)
- Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights
- Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
"Synopsis" may belong to another edition of this title.
About the Author
Harry Yang, Ph.D., is Vice President and Head of Biometrics at Fate Therapeutics. He has 25 years of experience across all aspects of drug research and development, from early target discovery, through pre-clinical, clinical, and CMC programs to regulatory approval and post-approval lifecycle management. He has published 7 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP.
Binbing Yu, Ph.D., is Associate Director in the Oncology Statistical Innovation group at AstraZeneca. He serves as the statistical expert across the whole spectrum of drug R&D, including drug discovery, clinical trials, operation and manufacturing, clinical pharmacology, oncology medical affairs and post-marketing surveillance. He obtained his PhD in Statistics from the George Washington University. His primary research interests are clinical trial design and analysis, cancer epidemiology, causal inference in observation studies, PKPD modeling and Bayesian analysis.
"About the title" may belong to another edition of this title.
Rarewaves.com USA
London, London, United Kingdom
AbeBooks seller since June 11, 2025
Shipping rates from United Kingdom to U.S.A.
| Item | 9 to 14 business days | 9 to 14 business days |
|---|---|---|
| First item | £ 0.00 | £ 0.00 |
Payment methods
Seller's business information
RAREWAVES.COM LIMITED
Elsley Court, 20-22 Great Titchfield Street
London, United Kingdom W1W 8BE
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 Rarewaves.com USA, Unit 144 The Lightbox, 111 Power Road, W4 5PY, London, London, United Kingdom, 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
Please note that we do not offer Priority shipping to any country.
We currently do not ship to the below countries:
Russia
Belarus
Ukraine
Please do not attempt to place orders with any of these countries as a ship to address - they will be cancelled.