Glossary

3

3R principle

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).
B

Biodiversity

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

Biosimilars

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 EMA (European Medicines Agency), biosimilars must demonstrate comparability, or biosimilarity, to an existing approved product.
C

Chromatography

A technique used to separate mixtures.

CLP

The European CLP regulation (Classification, Labelling and Packaging of Substances and Mixtures) is based on the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.

CO2eq

Short for CO2 equivalents, this indicates how much a specified quantity of a specific greenhouse gas has contributed to the greenhouse effect and uses the global warming potential of carbon dioxide as a reference.

Compliance

Adherence to laws and regulations as well as to voluntary codices that are internal to Merck KGaA, Darmstadt, Germany. Compliance is a component of diligent corporate governance.

CRISPR/Cas

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

Design thinking

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.

Disease burden

The impact of a health problem, often measured in terms of quality-adjusted life years or disability-adjusted life years, both of which quantify the number of years lost due to disease.

Dual-use products

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

Due diligence

A risk analysis exercised with particular care that is done in preparation for a business transaction.
E

EHS

Environment, Health and Safety describes environmental management, health protection and occupational safety throughout the company.

End-user declaration

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

Endemic countries

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

Essential medicines

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

Exposure assessment

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.
F

FDA

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.

First-line treatment

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.
G

Global Grade

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

Global Product Strategy

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.

Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

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

Good clinical practice (GCP)

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

Good distribution practice (GDP)

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

Good manufacturing practice (GMP)

Good manufacturing practices (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.

Greenhouse gases

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).

GxP

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.
H

Hackathon

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.

HazCom 2012

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.
I

ICH

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 makes recommendations toward achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration.

In vitro

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

In vivo

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

Investigational drug

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.

ISO 14001

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

ISO 50001

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

ISO 9001

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

Least developed countries (LDC)

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

Liquid Crystals (LC)

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.

Liver-stage malaria

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, no treatment of this dormant form is possible.

LTIR

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.
M

Mutagen

A substance that changes the DNA of an organism.
N

Neglected tropical disease (NTD)

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

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

OHSAS

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

OLED

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

Onchocerciasis

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.

Orodispersible tablet

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.
P

Patent pool

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

Patient support program

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

Pharmacovigilance

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

Phase I study

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 study

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 study

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/

Prediabetes

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

Product safety summary

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

PS-VA

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, allowing them 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.

Public-private partnership (PPP)

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

REACH

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.

Reproductive health

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

Role

Merck KGaA, Darmstadt, Germany uses 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).
S

Schistosomiasis

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

Scope 3

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

Security

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 Merck KGaA, Darmstadt, Germany.

Stakeholder

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.

STEM

Science, technology, engineering, and mathematics.

Stem cells

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

Sugar cane bagasse

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

Sunshine Act

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.
T

Traces

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.

TRIPS

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.

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