Dose Finding and Beyond in Biopharmaceutical Development
Idioma: inglés
Editorial: Springer, 2025
- Tapa blanda
- Nuevo

Librería: preigu, Osnabrück, Alemaniapreigu
Vendedor de IberLibro desde 5 de agosto de 2024
Condición: Nuevo
EUR 149,10
Cantidad disponible: 5 disponibles
Añadir al carritoDescripción del artículo del vendedor
Dose Finding and Beyond in Biopharmaceutical Development | Jingjing Ye (u. a.) | Taschenbuch | ICSA Book Series in Statistics | xvii | Englisch | 2025 | Springer | EAN 9783031671128 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
N° de ref. del artículo 135781766
- Título
- Dose Finding and Beyond in Biopharmaceutical Development
- Autor
- Jingjing Ye (u. a.)
- Editorial
- Springer
- Año de publicación
- 2025
- Estado
- Neu
- Encuadernación
- Taschenbuch
- Idioma
- inglés
- ISBN 10
- 3031671120
- ISBN 13
- 9783031671128
- Peso del artículo
- 417 gramos
- Dimensiones
- 235 x 155 x 15 mm
- Catálogos de vendedores
- Bücher
This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development.
Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase Ⅱ clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase Ⅲ confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs.
The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development.
“Sinopsis” puede pertenecer a otra edición de este título.
Acerca del autor
Jingjing Ye is a Fellow of American Statistical Association and is currently an executive director and global head of Data Science and Digital Innovations (DSDI), with Global Statistics and Data Sciences (GSDS) in BeiGene. She leads a global team with diverse background supporting business functions in R&D and outside R&D for their data, analytics and technology support. She has over 17 years' experience in pharmaceutical industry and US FDA, with focus in cancer drug discovery and development. Her statistical and regulatory experience expands full spectrum on patients' treatment journey from diagnosis, treatment, to living with the condition. Her main research interest is the innovative trial designs and analyses related to small populations, e.g., pediatric and rare diseases. She received her PhD degree in statistics from University of California, Davis and BS in applied mathematics from Peking University.
Ding-Geng Chen is a fellow of the American Statistical Association and is currently the executive director and professor in biostatistics at the College of Health Solutions, Arizona State University. He is also an extraordinary professor and the SARChI in biostatistics at the University of Pretoria, an honorary professor at the University of KwaZulu-Natal, South Africa. Dr. Chen has more than 200 referred professional publications and co-authored and co-edited 35 books on clinical trial methodology, meta-analysis, data science, causal inference, and public health research.
Wen Zhou is an Associate Professor in the Department of Biostatistics at the School of Global Public Health, New York University. He is an elected member of International Statistical Institute. His research area includes high dimensional inference, statistical genomics and genetics, network analysis, robust statistics, and causal inference. Currently, he is serving as the associate editor for Biometrics, Journal of Multivariate Analysis, Statistica Sinica, as well as the Co-editor in chief of the Journal of Biopharmaceutical Statistics.
Qiqi Deng is a Director in Clinical Biostatistics at Moderna. Her main research area includes hypothesis testing and modeling in dose finding, adaptive design, and pragmatic considerations in applying innovative methodology into real clinical studies. She publishes on wide array of statistical topics in her main area and beyond, e.g. multiplicity adjustment, Bayesian statistics
Joseph C. Cappelleri is an executive director of biostatistics at Pfizer Inc, his employer since June 1996, and is the recipient of the company's Craig A. Saxton Clinical Development Excellence Award. He has co-authored approximately 1,350 external presentations and 650 publications on clinical and methodological topics, including on regression discontinuity designs, meta- analysis, and health measurement scales. Dr. Cappelleri is the lead author of the book Patient-Reported Outcomes: Measurement, Implementation and Interpretation and has co-authored or co-edited four other books (Statistical Topics in Health Economics and Outcomes Research, Phase II Clinical Development of New Drugs, Design and Analysis of Subgroups with Biopharmaceutical Applications, A Practical Approach to Quantitative Validation of Patient-Reported Outcomes: A Simulation-Based Guide Using SAS).
“Acerca de” puede pertenecer a otra edición de este título.
preigu
Osnabrück, Alemania
Vendedor de IberLibro desde 5 de agosto de 2024
Tarifas de envío de Alemania a Estados Unidos de America
| Artículo | De 60 a 60 días hábiles | De 60 a 60 días hábiles |
|---|---|---|
| Primer artículo | EUR 70,00 | EUR 70,00 |
Métodos de pago
- PayPal
Descripción de la tienda
preigu betreibt einen Onlineversandhandel mit über 1 Mio. Produkten in verschiedenen Sortimenten. Das Kernsortiment besteht aus Büchern, Medien und Spielwaren. Ein gelungenes Einkaufserlebnis ist das Ziel einer jeden Bestellung bei preigu, denn der Kunde und seine Zufriedenheit stehen an erster Stelle. preigu setzt daher auf einen kompetenten Kundenservice, funktionierende Prozesse und schnelle Reaktion.
Especialidad
Bücher, SpielwarenInformación empresarial del vendedor
preigu GmbH & Co. KG
Lengericher Landstraße 19
Osnabrück, Alemania 49078
Condiciones de venta
About Us
Legal website operator identification:
preigu GmbH & Co. KG
Lengericher Landstr. 19
49078 Osnabrück
Germany
Telephone: +49 (0) 541 / 580 72 84
Email: mail@preigu.de
VAT No: DE 455 380 498
AG Osnabrück - HRA 209647
PhG: preigu Verwaltung GmbH
AG Osnabrück - HRB 221793
CEO: Ansas Meyer
We are neither willing nor obliged to participate in dispute resolution proceedings before consumer arbitration boards.
We are a member of the initiative "FairCommerce" since 30.11.2016.
For more information, see: https://www.haendlerbund.de/de/haendlerbund/interessenvertretung/faircommerce
Derecho al desistimiento
Instructions for revocation
Right of withdrawal for the sale of goods
Revocation right for consumers
(A ‘consumer' is any natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities.)
Instructions for revocation
Revocation right
You have the right to revoke this contract within 14 days without specifying any reasons.
The revocation period is 14 days with effect from the day,
-
on which you or a third party nominated by you, which is not the carrier, had taken possession of the products, provided you had ordered one or more products within the scope of a standard order and this/these product/products is/are delivered uniformly;
-
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last product, provided you had ordered several products within the scope of a standard order and these products are delivered separately;
-
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last part delivery or the last unit, provided you had ordered a product, which is delivered in several part deliveries or units;
To exercise your right of withdrawal, you must inform us (preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, Telephone number: +49 (0) 541 / 580 72 84, E-Mail address: mail@preigu.de) by means of a clear declaration (e.g. a letter sent by post, or an e-mail) of your decision to withdraw from this contract. You can use the attached model withdrawal form for this purpose, which is, however, not mandatory.
You can also exercise your right of withdrawal online by clicking on a button labelled accordingly (such as ‘Withdraw from contract' or similar) on the AbeBooks/ZVAB website. If you use this online function, you will immediately receive a confirmation of receipt on a durable medium (e.g. via email) containing information on the content of the withdrawal notice, as well as the date and time of its receipt.
In order to safeguard the revocation period, it is sufficient that you send the notification about the exercise of the revocation right before the expiry of the revocation period.
Consequences of the revocation
If you revoke this contract, we shall repay all the payments, which we received from you, including the delivery costs (with the exception of additional costs, which arise from that fact that you selected a form of delivery other than the most reasonable standard delivery offered by us), immediately and at the latest within 14 days from the day on which we received the notification about the revocation of this contract from you. We use the same means of payment, which you had originally used during the original transaction, for this repayment unless expressly agreed otherwise with you; you will not be charged any fees owing to this repayment.
We can refuse the repayment until the products are returned to us or until you have furnished evidence that you have sent the products back to us, depending on whichever is earlier.
You must return or transfer the products to us immediately and, in any case, at the latest within 14 days with effect from the day on which you inform us of the revocation of this contract. The deadline is maintained if you send the products before the expiry of the 14 day deadline.
You bear the direct costs for returning the products.
You must pay for any depreciation of the products only if this depreciation can be attributed to any handling with you that was not necessary for checking the condition, features and functionality of the products.
Criteria for exclusion or expiry
The revocation right is not available for contracts
-
for delivery of products, which are not prefabricated and for whose manufacturing an individual selection or stipulation by the consumer is important or which are clearly tailored to the personal requirements of the consumer;
-
for delivery of products, which can spoil quickly or whose use-by date would be exceeded quickly;
-
for delivery of alcoholic drinks, whose price was agreed at the time of concluding the contract, which however can be delivered 30 days after the conclusion of the contract at the earliest and whose current value depends on the fluctuations in the market, on which the entrepreneur has no influence;
-
for delivery of newspapers, periodicals or magazines with the exception of subscription contracts. The revocation right expires prematurely in case of contracts
-
for delivery of sealed products, which are not suitable for return for reasons of health protection or hygiene if their seal has been removed after the delivery;
-
for delivery of products if they have been mixed inseparably with other goods after the delivery, owing to their condition;
-
for delivery of sound or video recording or computer software in a sealed package if the seal has been removed after the delivery.
Specimen - revocation form
(If you wish to revoke the contract, please fill up this form and send it back to us.)
-
To preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, Email address: mail@preigu.de :
-
I/we () herewith revoke the contract concluded by me/ us () regarding the purchase of the following products ()/
the provision of the following service () -
Ordered on ()/ received on ()
-
Name of the consumer(s)
-
Address of the consumer(s)
-
Signature of the consumer(s) (only in case of a notification on paper)
-
Date
(*) Cross out the incorrect option.