New drug development: A regulatory overview

Mark P. Mathieu

OMEC International

New Drug Development: A Regulatory Overview

Parexel International Corp.

PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2016/2017 is the leading resource for statistics, trends, and proprietary market intelligence and analyses on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development from product discovery, to R&D performance and productivity, to time-to-market trends. With real-world analysis and key contributions from leading consultancies and experts, the Sourcebook includes: * New proprietary analysis on US clinical trial starts, segmented by therapeutic category, as well as overall active clinical trials * Emerging data on worldwide and company-specific R&D pipelines and product launch trends * New analysis on emerging trends in pharma and biotech licensing deals and other partnerships critical to industry's R&D pipeline* Drug approval statistics compiled from FDA, EMA, and other regulatory agencies * New global R&D spending trends and other international R&D data from key markets * International statistics on drug development output... And much more! Spotlight analyses on emerging and re-emerging elements of industry's R&D pipeline, including immuno-oncology, antibiotics, and gene therapy * Assessments of several emerging industry controversies, including drug pricing, the wisdom of ultra-rapid new drug reviews, and R&D overcrowding in some parts of the new drug pipeline * Analyses on the state, nature, and sustainability of industry's pipeline of R&D projects * Detailed profiles on the pipelines and emerging R&D models and structures used by leading pharma companies * Analyses focused on the drug and biopharma markets and development pipelines within emerging countries, including South Korea and China * Assessments of personalized medicine/companion diagnostics, biosimilars, orphan drugs, and other factors reshaping biopharma R&D today. PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2016/2017 is a must-have resource for the drug development industry. It is invaluable to executives and managers working in the pharma and biotech industries. The Sourcebook puts real-world data sets at your fingertips for presentations, reports, business development efforts, strategic meetings, and critical decision-making analyses.

PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2016/2017

Reference

Parexel Intl Corp

PAREXEL Biopharmaceutical R&amp;D Statistical Sourcebook 2018/2019 is the leading resource for R&amp;D statistics, trends, and proprietary market intelligence and analyses on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development from product discovery, to R&amp;D performance and productivity, to time-to-market trends. With real-world analysis and key contributions from leading consultancies and experts, the Sourcebook includes: * New proprietary analysis on US clinical trial starts, segmented by therapeutic category, as well as overall active clinical trials. * Assessments of personalized medicine/companion diagnostics, biosimilars, orphan drugs, and other factors reshaping biopharma R&amp;D today. * The latest analyses on clinical trial success rates, broken down by clinical trial phase and therapy area. * All-new analyses on who owns today s R&amp;D pipeline, R&amp;D spending, and new drug/biologics approvals by company size and type (pharma vs. biotech). * Emerging data on worldwide and company-specific R&amp;D pipelines and product launch trends. * New analyses on emerging trends in pharma and biotech licensing deals and other partnerships critical to industry s R&amp;D pipeline. * Drug approval statistics compiled from FDA, EMA, and other regulatory agencies. * New global R&amp;D spending trends and other international R&amp;D data from key markets. * Spotlight analyses on emerging and re-emerging elements of industry s R&amp;D pipeline, including immunooncology, microbiome R&amp;D, and cell/gene therapy. * Assessments of several emerging industry controversies, including drug pricing, the wisdom of ultra-rapid new drug reviews, and R&amp;D overcrowding in some parts of the new drug pipeline. * Spotlight analyses on the FDA s expedited programs (breakthrough therapy, fast track, accelerated approval) and how their increased use is reshaping new drug development today. * Analyses on the state, nature, and sustainability of industry s pipeline of R&amp;D projects. * Analyses focused on the drug and biopharma markets and development pipelines within emerging countries, including brand new analyses on Korea and China. **** PAREXEL Biopharmaceutical R&amp;D Statistical Sourcebook 2018/2019 is a must-have resource for the drug development industry. It is invaluable to executives and managers working in the pharma and biotech industries. The Sourcebook puts real-world data sets at your fingertips for presentations, reports, business development efforts, strategic meetings, and critical decision-making analyses.****

PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2018/2019

Anne G. Evans

Eric L. Hurden

Health, Fitness & Dieting

Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, 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 Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements. * How the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes. * How CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process. * How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions. * Which drug development 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. 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.

New Drug Development : A Regulatory Overview

Medical Books

Medicine

Barnett Educational Services / Chi

This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. 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

Science & Math

Mark Mathieu

Mathieu, Mark P.

Biological Sciences

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010 is the leading resource for statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analysis, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development - from product discovery, to R&D performance and productivity, to time-to-market trends.With key analysis and contributions from leading consultancies and experts, the sourcebook provides real-world data and analysis, including:* New proprietary analysis on US clinical trial starts, segmented by therapeutic category, as well as overall active clinical trials* Emerging data on worldwide and company-specific R&D pipelines and product launch trends* An all-new and comprehensive analysis of clinical research off-shoring revealing which pharma companies are now locating their new clinical trials overseas* New analysis on emerging trends in pharma and biotech licensing deals and other partnerships critical to industry's efforts* Drug approval statistics compiled from FDA, EMEA, and other regulatory agencies* New global R&D spending trends and other international R&D data from key markets* International statistics on drug development output...and much more!PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010 is a must-have resource for the drug development industry. It is an invaluable resource for executives and managers working in the pharma and biotech industries. The Sourcebook puts real-world data sets at your fingertips for presentations, reports, business development efforts, strategic meetings, and critical decision-making analyses.

Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2009-2010

Newly updated and expanded for 2011, this industry-leading GCP training and reference guide answers approximately 800 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 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, India, Latin America 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. With the completely updated and expanded 2011 guide, read how the FDA will now be focusing more intently on sponsors' "quality systems" when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. 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 * Now includes a new section on GCP in Latin America! * Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source! New in 2011: Need-to-know information related to the March 2011 updated version of the FDA s compliance policy guide manual (CPGM) 7348.810, which reveals the agency s goals and specific procedures for FDA field investigators in conducting, sponsor/monitor/CRO inspections. 60+ pages of all-new Q&amp;As, including questions addressing emerging topics such as the use of social media in clinical trials, and the implications of IRB reviews of social media content used for patient recruitment. A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities and direction of the FDA's GCP enforcement programs. Completely new and updated section featuring all the latest data and trends on the FDA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments.

Good Clinical Practice: A Question & Answer Reference Guide, May 2011

Encyclopedias & Subject Guides

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