Glossary

The international guiding principle for all animal testing. The number of laboratory animals used as well as the stress placed on them before, during and after testing are to be kept to an absolute minimum by using methods to replace animal experiments (replacement), reduce the required number of tests and animals (reduction), and improve the test methods (refinement).

Extremely large data sets that may be analyzed computationally to reveal patterns, trends and associations, especially relating to human behavior and interactions.

The diversity of ecosystems, habitats and landscapes on earth, the diversity of the species, and the genetic diversity within a biological species or population.

Officially approved subsequent versions of innovator biopharmaceutical products made by a different company after the original product's patent or exclusivity expires. Based on guidance from the European Medicines Agency (EMA), biosimilars must demonstrate comparability, or biosimilarity, to an existing approved product.

A chatbot is a computer program or an artificial intelligence that conducts a conversation via auditory or textual methods.

A technique used to separate mixtures.

Short for “Classification, Labelling and Packaging of Substances and Mixtures”, this is a European regulation based on the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.

CO₂ equivalents (CO₂eq) indicate how much a specified quantity of a specific greenhouse gas has contributed to the greenhouse effect, using the global warming potential of carbon dioxide as a reference.

Adherence to laws and regulations as well as to voluntary codices that are internal to a company. Compliance is a component of diligent corporate governance.

A biomolecular method for targeting, cutting and editing the DNA of an organism (gene editing). Experts think this technique has great potential for curing diseases or generating plants and animals with new traits.

An approach to developing new ideas. Design thinking uses the designer’s sensibility and methods to match people’s needs with what is technologically feasible and what a viable business strategy can convert into customer value and market opportunity.

Goods that are normally used for civilian purposes, but that may also have military applications.

A risk analysis exercised with particular care.

Short for “Environment, Health and Safety”, this refers to environmental management, health protection and occupational safety throughout a company.

A binding customer statement regarding the intended use of a product.

Countries in which a certain disease, in many cases an infectious disease, occurs.

EQ stands for our Group function “Environment, Health, Safety, Security, Quality”.

ESG ratings are used to assess a company’s financial performance through factors that include aspects of environmental management, social issues and good governance.

Defined by the World Health Organization as “those drugs that satisfy the health care needs of the majority of the population”.

The U.S. Environmental Protection Agency defines exposure assessment as the determination or estimation (qualitative or quantitative) of the magnitude, frequency, duration, and route of exposure between an agent and an organism. This analysis forms part of the chemical safety assessment process.

The U.S. Food and Drug Administration is the U.S. government agency responsible for protecting and advancing public health, especially as concerns food and drugs.

A therapy regimen that is generally accepted by the medical establishment for the initial treatment of a given disease. If the first-line treatment is not adequately successful, a second-line treatment may be administered.

Water containing 1,000 mg or less of dissolved solids per liter.

Gene drive technologies refer to methods for accelerating the spread of genes in populations. In general, the technique can employ adding, deleting, disrupting, or modifying genes. These can be used, for example, on mosquitoes that transmit malaria, dengue, and zika pathogens in order to stop their spread.

We use a market-oriented system to rate positions within the company. Until the end of 2016, all positions within the Merck KGaA, Darmstadt, Germany were assigned a Global Grade. In 2017, we replaced this system so that each position is now assigned a role.

An initiative of the International Council of Chemical Associations (ICCA) through which participating companies of the chemical industry make a commitment to comprehensive product responsibility.

An international standard system to classify chemicals that covers labeling as well as safety data sheets.

An international quality standard that enforces tight guidelines on ethical aspects of clinical studies.

An EU guideline that regulates the proper distribution of medicinal products for human use.

Good manufacturing practice (GMP) is a system for ensuring that products are consistently manufactured and controlled according to quality standards. These guidelines are used in the production of medicines, pharmaceutical active ingredients and cosmetics, as well as foodstuffs and feed.

Gases in the atmosphere that contribute to global warming. They can be either naturally occurring or caused by humans (such as CO₂ emissions caused by burning fossil fuels).

The general term for good (anything …) practice quality guidelines and regulations that are used in many fields, including the medical, pharmaceutical and pharmaceutical chemistry industries.

Portmanteau from the words hacking and marathon. A hackathon is an event attended by people from different professional backgrounds. Teams are given a few hours or days to develop innovative solutions and ideas for pre-defined issues or challenges.

A U.S. OSHA (Occupational Safety and Health Administration) standard pertaining to the safe handling of chemicals in the workplace, with an emphasis on occupational safety and environmental protection. This standard requires manufacturers and distributors to provide information on the hazards posed by a product as well as ways to minimize risks.

The aim of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to promote uniform assessment criteria for product registration in Europe, the United States and Japan. The ICH develops guidelines for the evaluation of the quality, effectiveness and safety of medicinal products.

Procedures involving components of an organism that have been isolated from their usual biological surroundings (e.g. test tube experiments).

Latin for “within the living”, this term describes processes that take place within a living organism.

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including approved as well as unapproved products when used or assembled (formulated or packaged) in a way different from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

This international environmental management standard sets globally recognized requirements for an environmental management system.

This international standard defines globally recognized requirements for energy management systems.

This international standard defines globally recognized requirements for a quality management system.

Manufacturers/importers of a certain substance must submit a joint registration according to REACH. In this context, the company responsible for collecting the substance data and preparing the registration dossier uses the term “lead substance”.

Countries that, according to the United Nations, exhibit the lowest indicators of socioeconomic development.

Sampling and analysis of non-solid biological tissue such as blood.

Liquid crystals are a hybrid of a crystalline and liquid state. In general, molecules are perfectly arranged only when in a solid crystal state, in contrast to the liquid state, when they move around chaotically. However, liquid crystals are a hybrid of the two states: Although they are liquid, they exhibit a certain crystalline arrangement. Their rod-shaped molecules align themselves like a shoal of fish. In addition, they respond to the electromagnetic waves of light like tiny antennae. Therefore, such swarms of molecules can either allow specially prepared “polarized” light to pass through, or they can block it. This takes place in the pixels of liquid crystal displays – as it does similarly in liquid crystal windows, which can provide shade against sunlight.

Certain forms of the malaria parasite (P. vivax and P. ovale) can remain dormant after they have infected the liver cells. In this stage, they persist for many weeks and even years until they relapse into a new disease cycle. Currently, it is not possible to treat this dormant form.

The lost time injury rate measures the number of accidents resulting in missed days of work (one or more days) per one million man-hours.

Monoclonal antibodies are made by identical immune cells that are all clones of a unique parent cell.

A substance that changes the DNA of an organism.

Diseases that occur primarily in developing countries. NTDs include schistosomiasis, intestinal worms, trachoma, lymphatic filariasis, and onchocerciasis. This group of diseases is called neglected because, despite the large number of people affected, they have historically received less attention and research funding than other diseases.

Nucleases are a group of enzymes whose primary function is to partially or fully degrade nucleic acids.

The Occupational Health and Safety Assessment Series (OSHAS) is an international occupational health and safety management system.

Organic light-emitting diodes are a new technology for displays and lighting.

A chronic parasitic infection caused by nematodes that occurs in the tropical regions of Africa and South America. In approximately 10% of those infected, the disease leads to blindness, which is why onchocerciasis is also referred to as river blindness.

An organoid is a miniaturized and simplified version of an organ produced in vitro in three dimensions by means of a cell culture. It shows realistic micro-anatomy similar to an organ. Organoids are derived from one or a few tissue cells, embryonic stem cells or induced pluripotent stem cells, which can self-organize in a three-dimensional culture, owing to their self-renewal and differentiation capacities. Organoids are, among others, used as model systems in the investigation of diseases and the development of drugs.

A tablet that dissolves in the mouth within 30 seconds and does not have to be taken with water. The active ingredient is absorbed through the mucous membrane in the mouth and also partly through the lining of the stomach.

Water containing more than 1,000 mg of dissolved solids per liter.

A consortium of at least two competing companies that allows partners to share the use of patents relating to a particular technology.

Self-sustaining commercial programs with revenue-driven purpose which provide medication for underserved populations, either through free products or a reduced treatment fee.

Any organized system providing services and direct patient or patient-caregiver interactions that are intended and designed to educate patients about certain diseases, and help patients with access to and/or the management of prescribed medication and/or disease outcomes and/or offer doctors support for their patients.

The continual, systematic monitoring of a drug's safety.

Phase I clinical trials test a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to evaluate safety (for instance to determine a safe dosage range and to identify side effects).

Source: http://www.who.int/ictrp/glossary/en/

Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.

Source: http://www.who.int/ictrp/glossary/en/

Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

Source: http://www.who.int/ictrp/glossary/en/

A condition regarded as indicative that a person is at risk of progressing to Type 2 diabetes.

Greenhouse gases released into the atmosphere during manufacturing operations.

Intended to provide a general overview of the chemical substance and its use. It cannot take the place of a safety data sheet.

Abbreviation for polymer-stabilized vertical alignment: A polymer layer pre-aligns the molecules inside the display in a certain direction. In the black state, the liquid crystals are not exactly vertical, but slightly tilted, which allows the liquid crystals to switch more quickly. The light transmittance of the display is significantly higher, thus reducing the backlighting, one of the most costly components to produce.

A collaboration between public sector (government) organizations, private companies and/or not-for-profit organizations.

A foreign substance that causes a fever (temperature elevation) in the body.

A European Union chemical regulation (EC No. 1907/2006) that took effect on June 1, 2007. REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals.

The term covers various areas such as pregnancy, sexually transmitted diseases, contraception, and infertility.

An agreement between the producer or manufacturer and the payer or provider that allows access to a health technology through coverage or reimbursement under certain conditions.

We use a market-oriented system to rate positions within the company. To facilitate consistency across the organization, each position is assigned a specific role, with an overarching job architecture classifying each role as one of 11 levels, 15 functions and an array of career types (Core Operations, Services & Support Groups; Experts; Managers; Project Managers).

A parasitic disease spread in warm lakes and ponds by snails that serve as intermediate hosts.

Scope 3 includes indirect greenhouse gas emissions, such as the extraction and production of purchased materials, transport-related activities, waste disposal, and employee travel.

A scorecard is an evaluation tool for measuring, documenting and controlling activities using metrics.

Scrum is a framework for agile project management. It is a method that is simple, flexible and quick to deliver results.

This term stands for all necessary measures and governance activities to detect, analyze, handle, and mitigate security- and crime-based threats to the company. This helps to protect employees as well as the tangible and intangible assets of the company.

A set of activities performed to determine whether, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking.

If a side effect has occurred while using a medicine and this is being reported, this is called a “spontaneous report”, because the adverse reaction is reported spontaneously (for example by doctors or patients) and not in a study or an observational study.

People or organizations that have a legitimate interest in a company, entitling them to make justified demands. Stakeholders include people such as employees, business partners, neighbors in the vicinity of our sites, and shareholders.

Science, technology, engineering, and mathematics.

Stem cell lines are groups of stem cells derived from animal or human tissue. They can be cultivated in vitro and multiply indefinitely.

Undifferentiated cells with the potential to develop into many different cell types that carry out different functions.

A fibrous waste product of sugar refining that is left when sugarcane stalks are crushed to extract their juice.

The Sunshine Provisions of the U.S. Patient Protection and Affordable Care Act aim to create more transparent relationships between manufacturers of drugs, medical devices and medical aids on the one hand, and doctors and teaching hospitals on the other.

Substances dissolved in water that are present only in minute amounts. Also referred to as micropollutants, these are synthetic substances present in concentrations ranging from one nanogram to one microgram per liter of water.

Direct and indirect transfers of value, whether in cash, in kind or otherwise (e.g. promotional purposes).

The Agreement on Trade-Related Aspects of Intellectual Property Rights is an international legal agreement between all the member nations of the World Trade Organization. TRIPS seeks to ensure that the measures and procedures for enforcing intellectual property rights do not become a barrier to lawful trade.

This technique is about deliberately sharing and providing knowledge as well as forming relevant working relationships. The goal is to discover new topics and ideas.