Back by popular demand and newly updated for 2007!

Now available in spiral binding!

2007 CFR/ICH GCP Reference Guide

Ideal for new hire packets, giveaways, IRBs, regulatory personnel, QA/QC departments, institutions, site and management organizations, CRAs, sponsors, investigator meetings, research facilities, universities, hospitals and more!

The CFR/ICH GCP Reference Guide includes:

• CFR Title 21, Parts 11, 50, 54, 56, 58, 312 and 314
• ICH Good Clinical Practice Guidelines (E6)
• ICH Clinical Safety Data Management Guidelines (E2A)
• European Union Clinical Trials Directive

Get this Reference Guide CUSTOMIZED with your company logo in color and you can choose between perfect and spiral binding!

• Custom covers available on orders of 100 guides or more.
• Spiral binding surcharge applies.

BULK ORDER DISCOUNTS AVAILABLE
Orders of 100+ standard cover guides are only $7.95 per book!

New Third Edition!
Biologics Development: A Regulatory Overview

Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products. Biologics Development: A Regulatory Overview provides the most detailed analysis of each stage of the biological product development process available anywhere:

• CDER's emerging organization and processes for regulating and reviewing therapeutic biological products.
• CDER's processes for regulating and reviewing cellular and gene therapies, vaccines, and blood products.
• How CDER and CBER are evolving their procedures and requirements to address new challenges presented by the user-fee program, risk management priorities, and internal agency initiatives.
• Emerging standards for the clinical and nonclinical testing of biological products.

Edited by Mark Mathieu, PAREXEL International Corporation
300 pages, ISBN# 1-882615-67-0. Hardcover.

The Largest Compendium of Drug Approval Performance Metrics Ever Compiled!

The US Drug Approval Trends and Yearbook 2007/2008

Finally a comprehensive source for the very latest performance metrics and trend analysis on every key aspect of the new drug approval process — The US Drug Approval Trends and Yearbook 2007/2008!

Building on last year's widely read edition, the new 2007/2008 edition examines hundreds of key trends and metrics to provide industry with all-new benchmarks and metrics on which to assess their own performance, to plan their own R&D projects, and to assess the various drug approval options and strategies available to them.

The US Drug Approval Trends and Yearbook 2007/2008 provides an unprecedented number of in-depth analyses and benchmarks, including the following:

• NDA and NME first-cycle success rates, review outcomes, and trends
• Complete review and approval profiles for each NME and NDA, including cycles to approval, review times, and review outcomes
• Analysis of drug review times, review cycle outcomes and success rates by therapeutic category and standard vs. priority classification
• NDA and NME cycles to approval and review times through mid-2006
• The impact of priority review, fast track, accelerated approval, orphan drug status and related programs on review times and review outcomes
• Review outcomes, review times, and success rates for other key new drug submissions, including NDA resubmissions, efficacy supplements, and manufacturing supplements

Based on data compiled through internal studies, Freedom of Information requests to the FDA, and other public and private sources, our proprietary analyses will provide you with unique insights, benchmarks, and performance metrics in areas critical to the success of your R&D projects. We guarantee it!

Cost: $295. ISBN 1 1-882615-84-0. Softcover. Approx. 200 pages.

PAREXEL Expediting Drug and Biologics Development

All-New Second Edition!!

Expediting Drug and Biologics Development: A Strategic Approach 1999

By Steven E. Linberg, Ph.D., Cato Research

Using a unique "reverse-engineering" approach, authors with extensive experience in all disciplines of drug and biologic development show how careful planning and a sharp focus on the end-goals can be used to expedite development programs.

From the first preclinical testing to clinical trials to the NDA/PLA review, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive and improve each aspect of a development program's design and implementation.

The new, second edition of Expediting Drug and Biologics Development is not a summary of U.S. regulatory requirements. It is a "doer's" guide to drug and biologics development. With this book, you will learn to:

• understand preclinical data necessary to support a clinical program.
• critically evaluate the needs of the package insert and marketing application before getting deeply into clinical trials.
• use standardization to expedite the entire development process, from protocols to data presentation.
• critically assess the needs of the final report before developing the clinical protocol.
• use draft case report forms (CRF) to dictate the content of the procedures section of the clinical protocol.
• constructively consider the methods for data analysis in developing the clinical protocol.

Contents:

• Underlying Philosophy of the Approach to Clinical Research
  • Introduction
• The Overall Process for Development of Drugs and Biologics
  • The IND: Preparation and Maintenance
  • Preclinical Development
  • Product and Assay Development
  • The Annotated Package Insert and the Clinical Development Plan
  • The Market Application (NDA or PLA)
• Planning
  • FDA Meetings: Pre-IND and End-of-Phase II
  • Project Advisory Group
  • Anticipating the NDA/PLA
  • Establishing the Final Report Format and Content
  • Data Presentations
• Execution
  • The Analysis Plan: Study-Specific Tables and Figures
  • The Case Report Forms
  • The Protocol: Anticipating the Final Report
  • The Investigator's Brochure
  • Selecting an Investigator Conducting the Trial
  • Safety Assessment and Adverse Event Reporting
  • Quality Assurance of the Clinical Database
  • The Final Analysis and Report of a Clinical Trial
  • The Integrated Summary of Effectiveness
  • The Integrated Summary of Safety
• Templates: samples are provided of actual content and format of:
  • The IND
  • Standard Data Presentations
  • Standard Case Report Forms
  • Protocols
  • Informed Consent
  • Contracts between the sponsor and investigators
  • Final Reports
  • The NDA/PLA

August 1999, softcover, 500 pp. 1-882615-51-4 $145.00

Expanded and Updated for 2007!

GOOD CLINICAL PRACTICE: A QUESTION & ANSWER REFERENCE GUIDE 2007

For CRAs, investigators/sites, auditors, compliance, legal, and other clinical professionals...

"This book should be mandatory reading for every person involved in clinical research."
Munish Mehra, Ph.D., managing director, Global Drug Development Experts

Newly updated and expanded for 2007, this industry-leading GCP training and reference guide answers approximately 500 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP standards for drugs and biologics.

While continuing with a U.S./FDA focus, this innovative reference pocket guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, Canada, India, and Russia! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards.

In one pocket handbook, you'll have authoritative answers to hundreds of common and emerging questions, in 20+ GCP-related areas, right at your fingertips:

• FDA and ICH GCP Standards for Clinical Research
• Form FDA 1572-Statement of Investigator
• Informed Consent
• Patient Recruitment
• State Standards and GCP
• Source Data/Documentation
• Investigator/Site Requirements
• Clinical Monitoring
• Clinical Study Safety Reporting
• Clinical Trial Protocols/Protocol Changes/Protocol Violations
• Institutional Review Boards
• Quality Assurance Activities/Study Auditing/FDA Inspections
• Investigational Drug Accountability, Administration, and Labeling
• Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!

May 2007, Approx. 420 pp., ISBN # 1-882615-82-4, $39.95+ Shipping

"Unless you already know everything there is to know about GCP, we recommend that you buy this book. This book is excellent." Graeme Scott, Anjo Strik, and Jean Saint-Pierre in The Quality Assurance Journal

"The book is the most important advance in clinical research education in quite some time... A valuable tool that I recommend every clinical research professional have on their desk."
Lisa Zimmerman, MS, Director of QA and Regulatory Compliance, Duke Clinical Research Institute

"This book is already a leader among GCP references and one that offers an immediate return for readers."
William Hirschhorn, Drexel University College of Medicine

New Drug Development: A Regulatory Overview

Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:

• How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.
• Which strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process.
• What implications FDA initiatives in risk management/drug safety, good review management, and systems quality are holding for drug development programs and new drug reviews.
• How the FDA's pending reorganization will affect drug reviews going forward.
• What ways the common technical document (CTD) format and electronic submissions are reshaping marketing applications in the United States now that they have gained significant momentum.

Find out why New Drug Development is pharma/biotech's "go-to" resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.

389 pages, ISBN 1-882615-72-7, $145 plus shipping

All New and Updated Edition!

State-by-State Clinical Trial Requirements Reference Guide 2006

Today's US-based clinical trials must meet not just federal requirements, but an increasingly complex array of state-specific requirements as well. In fact, many areas critical to clinical studies—age of consent, drug dispensing, genetic testing, and legal representatives, among many others—are driven by state, and not federal, laws.

How do you monitor the requirements of all 50 states?

State-by-State Clinical Trial Requirements Reference Guide 2006 provides totally updated and expanded profiles of the clinical trial standards in all 50 states. This all-new resource breaks down each state's requirements in more than a dozen practical areas critical to your clinical research programs, including:

• State statutory structures for clinical trials
• Required notifications to state officials/offices
• Legal representative standards
• Age of consent
• Drug dispensing/administration requirements
• Informed consent, IRB, and clinical protocol requirements
• State licensing authorities (medical, nursing, pharmacy)
• Special state rules for cancer research
• State HIV testing rules
• State requirements for genetic testing

Our 2006 edition has been updated and expanded to address additional areas of state law applicable to clinical research. Among the additions to this year's new edition is a new section on state-by-state requirements applicable to the emerging area of genetic testing.

"DON'T LEAVE HOME WITHOUT IT... Given its very affordable price, there is no good reason why every clinical research professional involved in regulatory, legal or budget activities should not have a copy on their desk; maybe two copies, in case one is 'borrowed.'"
Norman M. Goldfarb, Editor, The Journal of Clinical Research Best Practices

Order Your Copy Today!

November 2006, Approx 200 pp., ISBN 1-882615-80-8, $49.95

All New Edition! And available on-line!

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008

"PAREXEL'S Bio/Pharmaceutical R&D Statistical Sourcebook is one of the most important sources for accurate industry and regulatory data, and for some tables it is the only source."
Bert Spilker, President, Bert Spilker & Associates, LLC

Get your copy of the leading compendium of pharma/biotech R&D trend data and market intelligence!

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008 is packed with more cutting-edge and proprietary intelligence and analyses not available anywhere else—for example:

• New proprietary analyses on US clinical trial starts, now segmented for the first time by therapeutic category, as well as overall active clinical trials, also segmented by therapeutic category. See how quickly the numbers of active clinical trials are growing, and precisely which therapeutic areas are driving this growth.
• An all-new and comprehensive analysis of clinical research offshoring in which we provide the first definitive analysis of the countries in which pharma companies are now locating their new clinical trials (based on new studies initiated in 2006). The results will surprise you. features hundreds of all-new, real-world studies, analyses, articles, and data sets providing fresh insights into the developments reshaping pharma R&D and the industry itself.

Supported by thousands of graphs, illustrations, and analyses, PAREXEL'S Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008 provides the latest intelligence on every aspect of pharmaceutical development--from product discovery to R&D performance and productivity to time-to-market trends.

An invaluable resource for executives and managers working within or with the pharma and biotech industries, this 2007/2008 compendium puts real-world data sets at your fingertips for presentations, reports, business development efforts, meetings, and critical decision-making analyses:

• New R&D Spending Trends (US and Global)
• International Statistics on Drug Development Output Industry-wide and Company-by-Company
• Emerging Data on the Worldwide and Company-specific R&D Pipelines and Product Launch Trends
• New Analyses on Drug Development Costs/Development Cycle Times/Attrition Rates
• Drug Approval Statistics Compiled from FDA, EMEA and other Key Regulatory Agencies
• International R&D Data from Key Global Markets

And in response to customer demand, the new 2007/2008 edition is once again available in electronic format. Gain instant access to the data, analyses, and benchmark provided in the hardcopy compendium on a fully searchable, hyperlinked and printable web-based edition!

From an in-depth analysis on the realities of migrating clinical trials to developing nations to advances in clinical trial simulation and genomics to emerging trends in industry's product pipeline and product success rates to the new demographics of US clinical investigators and clinical trial populations, make sure that your meetings, reports, presentations, and decision-making are based on the very best and latest data available today!

"This is an incredibly useful and reliable resource for anyone connected to the pharmaceutical and biotech industries: marketers, financial planners, investors, or researchers."
Judy Blaine, Librarian, ArQule, Inc., Business Information Alert

Copyright 2007, 400+pp., ISBN # 1-882615-83-2.
Price: $425 (hardcopy) or $1,200 (single-user web access plus hardcopy).