Shein-Chung Chow
Innovative Methods for Rare Disease Drug Development
Innovative Methods for Rare Disease Drug Development
YOU SAVE £3.68
- Condition: Brand new
- UK Delivery times: Usually arrives within 2 - 3 working days
- UK Shipping: Fee starts at £2.39. Subject to product weight & dimension
Couldn't load pickup availability
Excellent- More about Innovative Methods for Rare Disease Drug Development
Reviews critical issues in rare diseases drug development, such as endpoint selection, sample size requirement, and complex innovative design. Provides better understanding of statistical concepts and methods for regulatory review and approval. Clarifies controversial statistical issues. Makes recommendations for accurate and reliable evaluation of rare diseases regulatory submissions. Proposes innovative study designs and statistical methods, including n-of-1 trial design, adaptive trial design, and master protocols. Offers insight into current regulatory guidance on gene therapy for rare diseases.
Format: Paperback / softback
Length: 306 pages
Publication date: 30 May 2022
Publisher: Taylor & Francis Ltd
Reviews critical issues such as endpoint selection, sample size requirement, and complex innovative design in regulatory submissions for rare diseases. Provides a better understanding of statistical concepts and methods that can be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval. Makes recommendations to accurately and reliably evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols such as platform trials. Offers insight regarding current regulatory guidance on rare diseases drug development, such as gene therapy.
Reviews critical issues such as endpoint selection, sample size requirement, and complex innovative design in regulatory submissions for rare diseases. Provides a better understanding of statistical concepts and methods that can be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval. Makes recommendations to accurately and reliably evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols such as platform trials. Offers insight regarding current regulatory guidance on rare diseases drug development, such as gene therapy.
Weight: 590g
Dimension: 234 x 156 (mm)
ISBN-13: 9780367502904
This item can be found in:
UK and International shipping information
UK and International shipping information
UK Delivery and returns information:
- Delivery within 2 - 3 days when ordering in the UK.
- Shipping fee for UK customers from £2.39. Fully tracked shipping service available.
- Returns policy: Return within 30 days of receipt for full refund.
International deliveries:
Shulph Ink now ships to Australia, Belgium, Canada, France, Germany, Ireland, Italy, India, Luxembourg Saudi Arabia, Singapore, Spain, Netherlands, New Zealand, United Arab Emirates, United States of America.
- Delivery times: within 5 - 10 days for international orders.
- Shipping fee: charges vary for overseas orders. Only tracked services are available for most international orders. Some countries have untracked shipping options.
- Customs charges: If ordering to addresses outside the United Kingdom, you may or may not incur additional customs and duties fees during local delivery.
