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Guide to Drug Development

Guide to Drug Development

A Comprehensive Review & Assessment

9780781774246
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Description

Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards.

Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development.

Spilkers Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.

Product Details
LWW
41376
9780781774246
9780781774246

Data sheet

Publication date
2008
Issue number
1
Cover
hard cover
Pages count
1232
Dimensions (mm)
213 x 276
Weight (g)
2812

  • SECTION 1

    Introduction and Overview of a Company and the Industry

    Introduction to Drug Development

    Pharmaceutical Industry:: Definitions

    The Big Picture

    Standards:: Types, Uses, and Issues

    Pharma-think, Academic-think, and Government-think

    Pharma Sense versus Common Sense

    Section 2

    Basic Principles, Strategies, and Approaches

    Overview of Factors Affecting Drug Discovery

    The Drug Discovery Process

    Golden Rules of Drug Discovery

    The Drug Development Process

    Golden Rules of Drug Development

    Biotechnology

    Extrapolating Animal Safety and Efficacy Data to Humans

    Evaluating and Interpreting Data

    Stimulating Innovation and Increasing Efficiency with the Right Questions, People, Milieu, and Approaches

    A New Paradigm of Drug Development

    Future Environments for Drug Discovery and Development

    Section 3

    Corporate Organization and Management Issues

    Models of International Operations

    Organization at the Corporate Level

    Corporate Management

    Reducing Pharmaceutical Risk

    Enhancing Communication

    Personnel and Staffing Issues

    Competitive Intelligence

    Conflicts of Interest and Bias

    Crisis Management

    Mergers, Joint Ventures, and Alliances

    Pharmacopolitics

    Institutional Memory

    Differences among Pharmaceutical Companies

    Section 4

    External Corporate Relationships and Interactions

    Interactions and Relationships between Academicians and Industry

    Investigator-sponsored Research Proposals Submitted to Industry

    Technology Transfer from Academia to Industry

    Interactions between Pharmaceutical Companies

    Interactions with Trade Associations

    Interactions with Legislators and Government Agencies

    Interactions and Relationships with Healthcare Professionals

    Interactions with Patients and the Public

    Patient Package Inserts

    Interactions and Relationships with the Media

    Section 5

    Research and Development Organization, Management, and Assessments

    Organizing Research and Development

    Managing Research and Development and Avoiding Tangents

    Personnel Issues in Drug Discovery and Development

    Myths about the Pharmaceutical Industry and Drug Development

    Fads and Fashions in Drug Development

    The Many Facets of Reality:: Approaches to Issues and Problems

    International Organization and Management

    Project Management:: Balancing Line Function and Matrix Approaches

    Choosing the Number and Types of Drugs to Develop

    Choosing Standards for Developing Drugs

    Creating and Using Benchmarks

    Evaluating a Portfolio of Investigational Drug Projects

    Compassionate Use Programs

    Virtual Drug Development

    Developing and Marketing Orphan Drugs for Rare Diseases

    Productivity and Project Success

    Overview of Safety and Risk Management

    Developing Standard Operating Procedures

    Section 6

    Clinical Activities and Issues

    Introduction to Clinical Trials

    Creating a Clinical Strategy and Development Plan for a New Drug or Indication

    Designing and Implementing a Clinical Trial

    Questions to Ask about a Clinical Trial Protocol

    Dose-esponse Relationships in Clinical Trials

    Collecting and Interpreting Life Events Data in Clinical Trials

    Quality of Life and Pharmacoeconomics in Clinical Trials

    Overview of Phase 4 and Postapproval Clinical Activities

    Phase 4 Trials and Postapproval Pharmacovigilance Methodologies

    Feasibility of Multinational Trials

    Groups that Influence Protocol Design

    Monitoring and Auditing a Clinical Trial

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