New Drug Approval Process, Vol. 139
Author: Richard Guarino
Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.
Cheryl Lynn Nunn-Thompson
This book describes the drug development and approval process in the U.S., utilizing an integrated approach that compliments Food and Drug Administration (FDA) regulations. The purpose of the book is to present the necessary insight to those involved in new drug development on how to successfully bring new products to market. The book is needed because of significant changes in this process that have occurred within the last five years. The authors have attained their stated goal. This book is intended for scientists in the drug field; yet it is written at a level of understanding that may be appropriate for those not formally trained in scientific methods. The book may be most useful to professionals in the pharmaceutical industry or any individuals who need additional insight or timely information on various aspects of drug development and approval by the FDA. The book offers selected illustrations (tables and figures) and appendixes that are well organized and labeled, which greatly enhance the efficiency of the text. Pertinent FDA law (Title 21 of CFR) is extracted and current literature is well referenced. Some authors have referenced their chapters throughout while others have only included a bibliography. The organization of the chapters is logical and reflects the order necessary in drug development and approval. The table of contents and index are detailed and specific; this would allow the book for use as a reference text on this topic. Overall appearance primarily consists of text with selected black-and-white illustrations. The book provides essential and practical information on many aspects of drug development and approval in the U.S., and will be useful for science andbusiness applications within the pharmaceutical industry as well as academia. This edition discusses many recent changes that have occurred in the drug development process and attempts to forecast future trends in this field. The text may have benefited from more FDA-affiliated authors.
Doody Review Services
Reviewer: Cheryl Lynn Nunn-Thompson, PharmD, MBA (University of Illinois at Chicago College of Pharmacy)
Description: This book describes the drug development and approval process in the U.S., utilizing an integrated approach that compliments Food and Drug Administration (FDA) regulations.
Purpose: The purpose of the book is to present the necessary insight to those involved in new drug development on how to successfully bring new products to market. The book is needed because of significant changes in this process that have occurred within the last five years. The authors have attained their stated goal.
Audience: This book is intended for scientists in the drug field; yet it is written at a level of understanding that may be appropriate for those not formally trained in scientific methods. The book may be most useful to professionals in the pharmaceutical industry or any individuals who need additional insight or timely information on various aspects of drug development and approval by the FDA.
Features: The book offers selected illustrations (tables and figures) and appendixes that are well organized and labeled, which greatly enhance the efficiency of the text. Pertinent FDA law (Title 21 of CFR) is extracted and current literature is well referenced. Some authors have referenced their chapters throughout while others have only included a bibliography. The organization of the chapters is logical and reflects the order necessary in drug development and approval. The table of contents and index are detailed and specific; this would allow the book for use as a reference text on this topic. Overall appearance primarily consists of text with selected black-and-white illustrations.
Assessment: The book provides essential and practical information on many aspects of drug development and approval in the U.S., and will be useful for science and business applications within the pharmaceutical industry as well as academia. This edition discusses many recent changes that have occurred in the drug development process and attempts to forecast future trends in this field. The text may have benefited from more FDA-affiliated authors.
Rating
3 Stars from Doody
Book about: Improving Service Quality in the Global Economy or Fourteen Ninety Two
The Project Manager's Guide to Software Engineering's Best Practices
Author: Mark Christensen
Since the earliest days of the computer industry, managing a software project has been a complex and demanding activity. While the technical content of software products and the technical methods used to build them have changed over time, the fundamental issues that determine the success or failure of software projects have remain fairly constant. That is, the same fundamental management mistakes continue to be made. To cite a few examples; requirements are unclear at the beginning of projects and are not managed during the project, the product is not tested adequately, schedules are misestimated or not tracked in sufficient detail. The contents of this book, together with the underlying IEEE Standards, are dedicated to helping the reader in their work: The continuing quest to produce quality software products in a predictable manner.
This book, containing all original material, is based on the proposition that the IEEE Software Engineering Standards capture many of the fundamental 'best practices' of software project management. It is written to assist the reader in applying those standards to their projects and company. To meet this goal, the authors discuss and elaborate the standards that bear on the three key management areas of: Software systems engineering, Processes for developing software products, Planning and control of software project activities.
The body of the book is correspondingly organized into three parts. Software Systems Engineering, which argues that software development projects are most successful when developed using a systems level viewpoint. Process Management and Control, which describes the key activities needed to define,support, and manage a project's software development processes. Project Planning and Management completes the book, integrating the elements of cost and schedule estimation and control, risk management, and the role metrics play in performing those tasks.
Table of Contents:
| Foreword | ||
| Preface | ||
| Acknowledgements | ||
| Reviewers | ||
| I | Software Systems Engineering | 1 |
| 1 | Software Systems Engineering | 5 |
| 2 | Concept of Operations | 41 |
| 3 | Software Requirements Specification | 63 |
| 4 | Software User Documentation | 95 |
| 5 | Software Verification and Validation | 113 |
| 6 | Software Maintenance | 149 |
| II | Process Management and Control | 175 |
| 7 | Software Life Cycle Process Management | 179 |
| 8 | Software Process Improvement | 209 |
| 9 | Software Configuration Management | 237 |
| 10 | Software Quality Assurance | 271 |
| 11 | Software Reviews | 291 |
| III | Project Planning and Management | 323 |
| 12 | Software Cost and Schedule | 327 |
| 13 | Software Engineering Project Management | 371 |
| 14 | Software Risk Management | 417 |
| 15 | Software Metrics | 449 |
| A | The Work Breakdown Structure | 497 |
| B | Representing Project Schedules | 501 |
| Index | 513 | |
| About the Authors | 531 |
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