Resource Center: Pharmaceutical References

Development and Implementation of Pharmaceutical Applications


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The Drug Development and Approval Process

These articles succinctly describe each of the phases in the drug development process in the United States and provide relevant information for each phase, such as the average duration and the expected rate of success in contributing to the approval of a new drug.  This is a useful introduction to those not familiar with this process.
An Overview of the Drug Development Process
http://www.italz.it/PRESS/phases.htm
http://www.allp.com/drug_dev.htm

The chart referenced below summarizes the unique attributes of each phase of the clinical trials development process.
http://www.clinicalresearch.pitt.edu/docs/comparison_of_clinical_trial_phases.pdf

Introduction to the clinical trials process.
An Introduction to Clinical Trials
BACKGROUNDER: How New Drugs Move through the Development and Approval Process



Standards Development Organizations / Data Standards
The following organizations are non-profit standards development bodies.

CDISC (Clinical Data Interchange Standards Consortium)
“CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry.”
http://www.cdisc.org

HL7 (Health Level 7)
“Health Level Seven is one of several ANSI-accredited Standards Developing Organizations (SDOs) operating in the healthcare arena.  Health Level Seven’s domain is clinical and administrative data. Our mission is to: To provide standards for the exchange, management and integration of data that support clinical patient care and the management, delivery and evaluation of healthcare services. Specifically, to create flexible, cost effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems."
http://www.hl7.org

FDA Data Standards Council
“The purpose of the FDA Data Standards Council (DSC) is to coordinate the evaluation, development, maintenance, and adoption of health and regulatory data standards to ensure that common data standards are used throughout the agency and the standards are consistent with those used outside the FDA. This is accomplished through strategically focused and systematic analysis of health and regulatory data standards requirements, evaluation of existing standards and adoption or development and maintenance of standards.
http://www.fda.gov/oc/datacouncil/



FDA Regulations
The following regulations can be found in the FDA’s Code of Federal Regulations.  Each is applicable to the major phases in the drug development life cycle.  GLP applies to the pre-clinical phase.  GCP applies to the clinical phases, and GMP applied to the production of drugs.

Good Laboratory Practice (GLP)
http://www.fda.gov/ora/compliance_ref/bimo/glp/87finalrule.htm

Good Clinical Practice (GCP)
http://www.fda.gov/cder/guidance/959fnl.pdf

Good Manufacturing Practice (GMP)
http://www.fda.gov/cder/dmpq/cgmpregs.htm

The entire Code of Federal Regulations is accessible here.
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199921



FDA Guidance
Following is a small subset of frequently referenced FDA guidance.

Glossary of Computerized System and Software Development Terminology
This document is referenced in many of the FDA’s guidance documents.
http://www.fda.gov/ora/inspect_ref/igs/gloss.html

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
http://www.fda.gov/cdrh/ode/software.pdf

General Principles of Software Validation
This document provides guidance for development of validated software (i.e. software that is fit for its intended use).
http://www.fda.gov/cdrh/comp/guidance/938.pdf

Electronic Records and Electronic Signatures (21 CFR Part 11)
The following describe the FDA’s rule for implementing electronic records and electronic signatures and provide guidance for applying the rule known as 21 CFR Part 11.
http://www.fda.gov/ora/compliance_ref/part11/

A list of all the FDA’s current guidance documents is available here.
http://www.fda.gov/cder/guidance/ 



Industry Associations
The following associations offer information, training and membership in different areas of interest within the life sciences domain.

DIA (Drug Information Association)
“Through the Center for Career & Professional Development (CC&PD), DIA strives to maintain its position as the premier organization within the health care arena for the exchange and dissemination of information by continuing to provide a neutral forum, respecting and welcoming all participants, and offering quality-driven programming.”
http://www.diahome.org

PhRMA (Pharmaceutical Research and Manufacturers of America)
“The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more prductive lives.” “PhRMA’s mission is winning advocacy for public policies that encourage the discovery of life-saving and life-enhancing new medicines for patients by pharmaceutical/biotechnology research companies.”
http://www.phrma.org

PDA
“PDA is a non-profit international association of more than 10,500 scientists involved in the development, manufacture, quality control and regulation of pharmaceuticals/biopharmaceuticals and related products.” “The mission of PDA is to advance pharmaceutical and biopharmaceutical technology internationally by promoting scientifically sound and practical technical information and education for industry and regulatory agencies.”
http://www.pda.org



Industry Resources

FDA (US Food and Drug Administration)
The website for Food and Drug Administration
http://www.fda.gov

ICH (International Conference on Harmonisation)
The official site for the ICH.
http://www.ich.org

Computer Validation Resource Center
This web site is a resource to direct interested parties to information about computer validation for the Pharmaceutical industry.
http://www.gentweb.net/compval/default.html

Pharmaceutical Education and Research Institute
“PERI is a not-for-profit organization that has been serving the pharmaceutical industry since 1989. Our entire operations revolve around providing you with the highest quality training available to assist you in your current position, and provide you with educational opportunities to enhance your long-term learning.”
http://www.peri.org/home.cfm?CFID=188233&CFTOKEN=17289577

Medical terms and definitions
The following Web sites are useful for referencing pharmaceutical and healthcare terminology.

Hyperdictionary Medical Dictionary
http://www.hyperdictionary.com/medical

Medical Dictionary Search Engine
http://www.books.md/index.html



Industry News and Information

FirstWord
FirstWord offers industry news as well as a daily e-mail subscription containing pharmaceutical news specifically.
http://main.pslgroup.com/psl.nsf/default?openform



Periodicals

Advanstar Communications
Advanstar offers a number of publications, including:·     

  • Applied Clinical Trials - The Global Guide to Clinical Trials Management
  • BioPharm International - The Applied Technologies of Biopharmaceutical Development·     
  • Pharmaceutical Executive - A Global Business and Marketing Publication
  • Pharmaceutical Technology

http://www.advanstar.com/index_markets.html 




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