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Appendix A: Glossary
Pages 309-330

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From page 309...
... : An initiative signed on October 1, 2011, by key trading partners to strengthen the international legal framework for effectively combating global proliferation of commercialscale counterfeiting and piracy. It calls for strong legal frameworks and innovative provisions to deepen international cooperation and to promote strong intellectual property rights enforcement practices.
From page 310...
... Attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy: A well-established, nondestructive method for determining the chemical composition of materials based on their chemical bonding.
From page 311...
... Central medical stores are generally responsible for the procurement, quality assurance, storage and distribution of drugs, vaccines, disinfectants, dressings, and related medical supplies for government health facilities and some nongovernment organizations. Chain of custody: A document intended to guarantee the integrity of a drug product along the distribution chain.
From page 312...
... The principal requirement for the issues of a compulsory license under TRIPS is that attempts to obtain a license under reasonable commercial terms must have failed over a reasonable period of time. TRIPS also provides that the requirements for a compulsory license may be waived in certain situations, in particular cases of national emergency or extreme urgency or in cases of public noncommercial use.
From page 313...
... It separates the nuclear magnetic resonance signals of different components according to their diffusion coefficient. Direct ionization: The impulses alpha and beta particles apply to orbital electrons to ionize, or completely remove an electron from an atom following the transfer of energy from a passing charged particle.
From page 314...
... Diversion: The unlawful channeling of products from a legitimate, parallel marketed, subsidized supply chain into other, unsubsidized markets. Doha Declaration: A declaration adapted by World Trade Organization members in 2001.
From page 315...
... Excipient: A pharmacologically inactive substance used along with the active pharmaceutical ingredients in the formulation of a medication. Expert review panel: A panel of independent experts, who review the potential risks and benefits associated with the use of finished pharmaceutical products or diagnostic products.
From page 316...
... Fourier-transform infrared spectrometry: A measurement technique whereby infrared spectra are collected based on nondispersive spectral measurements. As with all other infrared spectral measurements, this technique can identify unknown materials, determine the quality or consistency of a sample, and determine the amount of components in a mixture.
From page 317...
... Its composition and temperature play a major role in the separation process by influencing the partitioning between sample components and stationary sorbent. HPLC is one of the most powerful tools in analytical chemistry.
From page 318...
... Infrared spectroscopy: The spectroscopy that deals with the infrared region of the electromagnetic spectrum, that is, light with a longer wavelength and lower frequency than visible light. It covers a range of techniques, mostly based on absorption spectroscopy.
From page 319...
... Market authorization: An official document issued by the competent drug regulatory authority for the purpose of marketing or free distribution of a product after a satisfactory evaluation for safety, efficacy, and quality. Mass spectrometer: An instrument used to measure the precise masses and relative amounts of atomic and molecular ions.
From page 320...
... Medicrime Convention: The first international treaty established by the Council of Europe against counterfeit medical products and similar crimes involving threats to public health. The Convention makes it an offense to manufacture counterfeit medical products; supply, offer to supply, and traffic counterfeit medical products; falsify documents; manufacture or supply medicinal products without proper authorization; and market medical devices that do not comply with conformity requirements.
From page 321...
... spectroscopy: A technique that uses radiofrequency radiation to induce transitions between different nuclear spin states of samples in a magnetic field. NMR spectroscopy can be used for quantitative measurements, but it is most useful for determining a compound's unique structure and identifying the carbon-hydrogen framework of an organic compound.
From page 322...
... It encompasses the counterfeiting and falsification of medical products and their packaging and associated documentation, as well as theft, fraud, illicit diversion, smuggling, trafficking, the illegal trade of medical products, and the money laundering associated with it. Pharmacist: A person who is licensed to prepare, sell, dispense drugs and compounds, and write prescriptions.
From page 323...
... Radio frequency identification (RFID) : A wireless non-contact system that uses radio frequency electromagnetic fields to transfer data from a tag attached to an object, for the purposes of automatic identification and tracking.
From page 324...
... Unique codes are placed on each unit packaged, using variable data printers or preprinted labels or cartons, and then read by a vision system. These unique codes are uploaded to an event repository database that can be accessed by various parties, including pharmacists, law enforcement officials, and even consumers after the product is shipped and sold.
From page 325...
... Stringent regulatory authority: A national drug regulatory authority that participates in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
From page 326...
... Tandem mass spectrometry: A technique involving multiple rounds of mass spectrometry, usually separated by some form of molecule fragmentation. For example, one mass analyzer can isolate one peptide from many entering a mass spectrometer.
From page 327...
... TLC is performed on a sheet of glass, plastic, or aluminum foil, which is coated with a thin layer of adsorbent material, usually silica gel, aluminum oxide, or cellulose. This layer of adsorbent is known as the stationary phase.
From page 328...
... United States Adopted Names: Unique nonproprietary names assigned to generic pharmaceuticals marketed in the United States. United States Adopted Names Council: A five-member council consisting of one member from each sponsoring organization (the American Medical Association, the U.S.
From page 329...
... These techniques measure vibrational energy levels associated with the chemical bonds in a sample. The sample spectrum is unique, like a fingerprint, and vibrational spectroscopy is used for identification, characterization, structure elucidation, reaction monitoring, quality control, and quality assurance.
From page 330...
... 330 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS World Health Organization (WHO) prequalification program: A program managed by the WHO that prequalifies pharmaceutical and other health products that are considered to be acceptable for procurement by the United Nations and specialized agencies, and laboratories for quality control of such products.


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