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Glossary
- Analgesic
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Agent that relieves pain without causing loss of consciousness.
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CMC
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Chemistry Manufacture Control - part of document to be submitted
to regulatory boards called 'IND Application' and includes pre-clinical
study results. CMC + IB submission and approval will allow human
clinical studies to go forward.
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DEA
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Drug Enforcement Administration, the United States federal government
agency responsible for enforcement of drugs regulated by the FDA.
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Drug
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Any substance or mixture of substances manufactured, sold or
represented for use in the diagnosis, treatment or prevention
of a disease, disorder or abnormal physical state, or its symptoms,
in human beings or animals.
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Drug Product
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The drug substance in a liquid solution for an injectable format.
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Drug Substance
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The powder derived from refining the raw product.
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EMEA
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The European Medicines Evaluation Agency - an agency of the
European Union that regulates the quality, safety and effectiveness
of biological and pharmaceutical products in the European Union.
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FDA
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Food and Drug Administration - the United States federal government
agency that regulates the quality, safety and effectiveness of
biological and pharmaceutical products in the United States.
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- GCP
- Good Clinical Practices - refers to the regulations and requirements
that must be complied with while conducting a clinical study.
These regulations apply to the manufacturers, sponsors, clinical
investigators, institutional review boards and the medical device.
- GLP
- Good Laboratory Practices - a code of laboratory practices published
by the regulatory agencies (FDA/HC/EMEA) which provides a high
level of control and assurance in a laboratory facility.
- GMP
- Good Manufacturing Practices - a code of regulations set forth
by various Regulatory Agencies (FDA / HC/EMEA) for methods to
be used in the manufacture, processing, packing, or holding of
a drug to assure that such drug meets the requirements as to safety,
and has the identity and strength and meets the quality and purity
characteristics that it purports to.
- HC
- Health Canada or the Department of Health and Welfare, a federal
government department that regulates, through the Health Products
and Foods Branch, the quality, safety and effectiveness of biological
and pharmaceutical products in Canada.
- HPFB
- Health Products and Foods Branch of Health Canada
- IB
- Investigational Brochure (see CMC)
- ICH
- International Conference on Harmonization
- IND
- Investigational New Drug.
- IND Application
- An Investigational New Drug Application or Submission in Canada
and the United States to conduct a clinical trial in healthy human
volunteers or patients. An IND Application must include an Investigator's
Brochure or synopsis of all data pertaining to pre-clinical studies,
proposed clinical trials to be conducted, and a complete chemistry
and manufacturing document.
- IRB
- Investigational Revue Board - mostly in Europe and includes
the Ethical Revue Board in the institution where the sponsor (WEX)
is requesting the clinical work to be carried out.
- NDA/NDS
- New Drug Application/New Drug Submission - an application to
the FDA (NDA) or to the HC (NDS) for marketing approval for a
new therapeutic agent made upon successful completion of clinical
trials. The review time for a NDA is typically between 12 and
36 months and encompasses a review of all information related
to pre-clinical and clinical studies, chemistry and manufacturing
controls.
- NIDA
- United States National Institute on Drug Abuse.
- PCT
- Patent Treaty Cooperation
- Phase I, II & III
- The stages towards a NDA application after a successful IND
application. Phase IV is usually carried out by one of the major
drug companies, who by now are with you in a strategic alliance.
- SFDA
- State Food and Drug Administration - an agency of the government
of the People's Republic of China ('China') that regulates the
quality, safety and efficacy of biological and pharmaceutical
products in China.
- SOP
- Standard Operating Procedures - used by all pharmaceutical companies
to itemize all procedures in the manufacturing and any procedural
follow through.
- TSX
- The Toronto Stock Exchange (TSX) manages all aspects of Canada's
senior market providing Canadian trading and data to the global
financial community and an efficient liquid market for senior
equities. Listed companies on the senior exchange represent a
broad range of businesses from across Canada, the United States
and other countries.
- WHO
- World Health Organization (United Nations' Specialized Agency).
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