Compare Prices | Create Shopping Lists with Price Drop Alerts | Set Coupons, Promo Codes & Sales Alerts | Get Access to Exclusive Deals and Much More... All in One Place | Read all about it here

Quantitative Decisions in Drug Development

Quantitative Decisions in Drug Development

Brand
Springer Nature
Manufacturer
N/A
Part Number
0
GTIN
9783030797300
Condition
New
Product Description

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria tothe cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.

Available Colors
Available Sizes
1 Offer Price Range: $49.99 - $49.99
BEST PRICE

Single Product Purchase

$49.99
@ Link.springer.com     BUY Now

Price Comparison

Seller Contact Seller List Price On Sale Shipping Best Promo Final Price Volume Discount Financing Availability Seller's Page
BEST PRICE
1 Product Purchase
@ Link.springer.com
Contact Store Call Store Contact Support
$49.99 $49.99

$49.99
See Site In stock Visit Store

Similar Products

The Political Economy of Imperialism

$84.99

Biology and Biotechnology of the Plant Hormone Ethylene II

$169.00

Die Innenbauten rmischer Legionslager whrend der Prinzipatszeit

$84.99

Teaching Leadership and Organizational Behavior through Humor

$109.99

Differential- und Integralrechnung

$69.95

Induced Resistance to Disease in Plants

$169.99

Businesses in the Aftermath of the Crisis

$109.99

The Riemann Boundary Problem on Riemann Surfaces

$39.99

Proceedings of the 2nd International Symposium on Disaster Resilience and Sustainable Development

$169.99

In and Out of Equilibrium 3: Celebrating Vladas Sidoravicius

$119.00

Understanding Digital Humanities

$119.99

Qualittsmanagement in der Luftfahrtindustrie

$89.99

A Historical and Theological Investigation of John's Gospel

$129.99

IoT Edge Intelligence

$169.00

After Diagnosis: Family Caregiving with Hospice Patients

$39.99

Temporal Verification of Reactive Systems

$109.99

The Time-Travelling Economist

$29.99

Nachhaltige Logistik

$149.99

Renaissance Configurations

$54.99

Powers of Two

$54.99

Food-Borne Parasitic Zoonoses

$219.99

Methods of Model Based Process Control

$549.99

Types for Proofs and Programs

$39.99

Betriebswirtschaftslehre - Schnell erfasst

$24.99

Lesen lernen mit Erwachsenen nach dem IntraActPlus-Konzept

$17.99

Organisation und Geschlecht

$64.99

Metal Sites in Proteins and Models

$129.00

The Development of Bioethics in the United States

$159.99

Molecular Biomarkers for Cancer Diagnosis and Therapy

$219.00

Advances in Computer and Computational Sciences

$219.99

Cardiac Gene Therapy

$109.99

Newton and Religion

$169.99

Vom Leben zum Erleben

$44.99

Hydraulic Structure and Hydrodynamics

$59.99

Sustainability Awareness and Green Information Technologies

$84.99

Manual of Vibration Exercise and Vibration Therapy

$169.99

Kunsttherapeutische Gruppenarbeit in der psychoanalytischen Heilpdagogik

$69.99

A Study of the Turning Point of Chinas Debt

$89.00

Business Computing mit Navision-Systemen

$59.99

Wild New York

$44.99