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Good Laboratory Practice
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical (non-pharmaceutical) health and environmental safety–or simply toxicology–studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the toxicity testing of chemicals in commerce, to ensure the quality and integrity of the safety data submitted by manufacturers to regulatory authorities globally. History The historical events leading to the proposal of the Good Laboratory Practice (GLP) regulations are crucial for understanding why these regulations are important to improve the quality and integrity of chemical safety data. They were developed in response to concerns about the reliability of toxicity data from industry. The GLP regulations aim to standardize procedures and practices to ensure accurate, reliable, and traceable safety data. GLP was first introd ...
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OECD
The Organisation for Economic Co-operation and Development (OECD; , OCDE) is an international organization, intergovernmental organization with 38 member countries, founded in 1961 to stimulate economic progress and international trade, world trade. It is a forum (legal), forum whose member countries describe themselves as committed to democracy and the market economy, providing a platform to compare policy experiences, seek answers to common problems, identify good practices, and coordinate domestic and international policies of its members. The majority of OECD members are generally regarded as developed country, developed countries, with High-income economy, high-income economies, and a very high Human Development Index. their collective population is 1.38 billion people with an average life expectancy of 80 years and a median age of 40, against a global average of 30. , OECD Member countries collectively comprised 62.2% of list of countries by GDP (nominal), global nom ...
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Industrial Bio-Test Laboratories
Industrial Bio-Test Laboratories (IBT Labs) was an American industrial product safety testing laboratory. IBT conducted significant quantities of research for pharmaceutical companies, chemical manufacturers and other industrial clients; at its height during the 1950s, 1960s, and 1970s, IBT operated the largest facility of its kind and performed more than one-third of all toxicology testing in the United States. IBT was later confirmed of engaging in extensive scientific misconduct and fraud, which resulted in the indictment of its president and several top executives in 1981 and convictions in 1983. The revelations of misconduct by IBT Labs led to reforms in the regulation of pesticides in the United States and Canada. History Early years IBT was founded in 1953 by Joseph C. Calandra, an Italian American professor of pathology and biochemistry at Northwestern University. Calandra, the first of his family to pursue higher education, contributed to the concept of toxicological ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ...
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would ...
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European Commission
The European Commission (EC) is the primary Executive (government), executive arm of the European Union (EU). It operates as a cabinet government, with a number of European Commissioner, members of the Commission (directorial system, informally known as "commissioners") corresponding to two thirds of the number of Member state of the European Union, member states, unless the European Council, acting unanimously, decides to alter this number. The current number of commissioners is 27, including the president. It includes an administrative body of about 32,000 European civil servants. The commission is divided into departments known as Directorate-General, Directorates-General (DGs) that can be likened to departments or Ministry (government department), ministries each headed by a director-general who is responsible to a commissioner. Currently, there is one member per European Union member state, member state, but members are bound by their oath of office to represent the genera ...
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Clinical Laboratory Improvement Amendments
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. CLIA Program In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: * diagnosis, prevention, or treatment of disease or impairment * health assessments An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program. In 2014 the FDA started a public discussion about regulating some LDTs. Test Complexity Per CLIA, each specific laboratory system, assay, examination is graded for ...
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Good Clinical Practice
In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly develope ...
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Joint Committee For Traceability In Laboratory Medicine
The Joint Committee for Traceability in Laboratory Medicine or JCTLM is collaboration between the International Bureau of Weights and Measures (BIPM), the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC), and the International Laboratory Accreditation Cooperation (ILAC). The goal of the JCTLM is to provide a worldwide platform to promote and give guidance on internationally recognized and accepted equivalence of measurements in laboratory medicine and traceability to appropriate measurement standards. See also * Good laboratory practice (GLP) * Institute for Reference Materials and Measurements (IRMM) * Reference range * Reference values A reference is a relationship between Object (philosophy), objects in which one object designates, or acts as a means by which to connect to or link to, another object. The first object in this relation is said to ''refer to'' the second object. ... References External links Joint Committee for Traceabili ...
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International Laboratory Accreditation Cooperation
The International Laboratory Accreditation Cooperation or ILAC started as a conference in 1977 to develop international cooperation for facilitating trade by promoting the acceptance of accredited test and calibration results. In 1996, ILAC became a formal cooperation with a charter to establish a network of mutual recognition agreements among accreditation bodies that would fulfil this aim. The ultimate aim of the ILAC is increased use and acceptance by industry as well as government of the results from accredited laboratories, including results from laboratories in other countries. In this way, the free-trade goal of a 'product tested once and accepted everywhere' can be realised. See also * Accreditation * Good laboratory practice (GLP) * Institute for Reference Materials and Measurements (IRMM) * International Federation of Clinical Chemistry and Laboratory Medicine * ISO/IEC 17025 * Joint Committee for Traceability in Laboratory Medicine * Reference range * Reference ...
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International Federation Of Clinical Chemistry And Laboratory Medicine
The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a global professional association that promotes the fields of clinical chemistry and laboratory medicine. It was established in Paris in 1952 as the International Association of Clinical Biochemists to organize the various national societies of these fields and is based in Milan, Italy. The IFCC's aims are to set global standards, support and educate its members, and provide conferences and other gatherings for sharing knowledge among the global laboratory medicine community. IFCC members fall into three groups: national societies of clinical chemistry and laboratory medicine, corporations, and affiliate international or national societies involved in laboratory medicine. As of 2023, these members represented more than 45,000 individual clinical chemists, laboratory scientists, and laboratory physicians. Structure and organization The IFCC is governed by a council consisting of representati ...
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Drug Development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process—from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials—to approved vaccine or drug typically takes more than a decade. New chemical entity development Broadly, the process of drug development can be divided into preclinical and clinical work. Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These h ...
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