Monovalent vaccine

Vaccine designed to immunize against a single antigen or single microorganism. When vaccine immunize against more than one antigen, we call them bivalent (two antigens), trivalent (three antigens), quadrivalent (four antigens) vaccine.

Morbidity

The condition of suffering from a disease or medical condition.

Morbidity rate

The proportion of a particular population found to be affected by a medical condition (typically a disease) at a specific time.

Mortality

The state of being human and not living forever.

Mortality rate

The number of deaths (in general, or due to a specific cause) in a particular population, scaled to the size of that population, per unit of time. Mortality rate is typically expressed in units of deaths per 1,000 individuals per year.

Mother Liquor

The solution remaining after a component has been removed by a process such as filtration or crystallization.

mRNA Vaccine

A vaccine that uses mRNA to teach our cells how to make a protein—or even just a piece of a protein—that produces an immune response to a disease.

Mucosa

The moist soft tissue that covers the inside surface of parts of the body such as the nose, mouth, lungs, and stomach and produces mucus to protect them.

Mucosal membranes

The soft, wet tissue that lines body openings, specifically the mouth, nose, rectum, and vagina.

Multicenter Trial

A clinical trial that is carried out at more than one medical institution.

Multiple Sclerosis (MS)

A disease of the central nervous system characterized by the destruction of the myelin sheath surrounding neurons, resulting in the formation of “plaques.” MS is a progressive and usually fluctuating disease with exacerbations (patients feeling worse) and remissions (patients feeling better) over many decades. In most patients, remissions eventually do not reach baseline levels and permanent disability and sometimes death occurs. The cause of MS is unknown. The most widely held hypothesis is that MS occurs in patients with a genetic susceptibility and that some environmental factors “trigger” exacerbations. MS is three times more common in women than men, with diagnosis usually made as young adults. See demyelinating disorders.

Mutual Recognition

It occurs when two or more countries or other institutions recognize one another’s decisions or policies, for example in the field of conformity assessment, professional qualifications or in relation to criminal matters.

Monitor

The individual designated by the sponsor to oversee the monitoring of a clinical trial.

Multivalent vaccine

Vaccine designed to immunize against multiple antigens or microorganisms. When vaccine immunize against more than one antigen, we call them bivalent (two antigens), trivalent (three antigens), quadrivalent (four antigens) vaccine.

Monitoring

The activity of overseeing the progress of a clinical trial to ensure that it is conducted and recorded according to the clinical trial protocol, standard operating procedures, Good Clinical Practice (GCP), and applicable regulations.

Mumps

Acute contagious viral illness caused by mumps virus, marked by swelling, especially of the parotid glands.

Monitoring Report

A report documented by the monitor, who visits each clinical trial site or contacts them in relation to the clinical trial according to the sponsor’s standard operating procedures.

Murine

Relating to or affecting mice or related rodents.

Monoclonal antibody

An antibody produced from a single cell lineage made by cloning a unique white blood cell.

Myalgia

Medical term for muscle pain.

Monoclonal Antibody Drug

Monoclonal antibody that has therapeutic effect by rending its target ineffective, inducing a specific cell signal, causing the immune system to attack specific cells, or bringing a drug to a specific cell type.

Master Formula

A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produced a specified quantity of a finished product as well as the processing instructions, including the in-process controls.

Manufacturer

A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals.

Measles

A highly contagious, vaccine-preventable infectious disease caused by measles virus. Symptoms typically include fever, cough, runny nose, and inflamed eyes. A red, flat rash which usually starts on the face and then spreads to the rest of the body typically begins three to five days after the start of symptoms.

Margin of Safety (MOS)

The ratio of the lethal dose to 1% of population to the effective dose to 99% of the population (LD1/ED99). It is used to measure drug safety, and the bigger the ratio, the safer the drug is.

Messenger RNA (mRNA)

An RNA produced by transcription that carries the code for a particular protein from the nuclear DNA to a ribosome in the cytoplasm and acts as a template for the formation of that protein.

Marketing authorization / Product license / Registration certificate

A legal document issued by the competent medicines regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life.

Metabolite

A substance formed in or necessary for metabolism.

Memory

The ability of the immune system to quickly and specifically recognize an antigen that the body has previously encountered and initiate a corresponding immune response.

Mass spectrometry

A method used by scientists to measure and compare the mass and the electrical charge of ions, thereby determining the elemental or isotopic signature of a sample, the masses of particles and of molecules, and elucidating the chemical identity or structure of molecules and other chemical compounds.

Meningococcus

A bacterium involved in some forms of meningitis and cerebrospinal infection.

Mast cell

A type of white blood cell, that is high similar both in appearance and function to basophil. It is best known for their role in allergy and anaphylaxis, but is also plays an important protective role as in defense against pathogens.

Microbiome

The microorganisms in a particular environment (including the body or a part of the body).

Meta analysis

Statistical combination of the results of multiple studies addressing a similar research question.

Master record

A record opening document and any amendment or correction that serve as a basis for the batch documentation.

Microfluidics

Both the science which studies the behaviour of fluids through micro-channels, and the technology of manufacturing microminiaturized devices containing chambers and tunnels through which fluids flow or are confined.

Metabolic Stability

The susceptibility of compounds to biotransformation in the context of selecting and/or designing drugs with favourable pharmacokinetic properties.

Material Reconciliation

The process to confirm that the components obtained at the end of the manufacturing process match with the input amount of material entered and used.

Microorganism

An organism of microscopic size, which may exist in its single-celled form or as a colony of cells.

Metabolism

The chemical changes that take place in a cell or an organism. These changes make energy and the materials cells and organisms need to grow, reproduce, and stay healthy. Metabolism also helps get rid of toxic substances.

Material safety data sheet (MSDS)

A document that contains information on the potential hazards (health, fire, reactivity and environmental) and how to work safely with the chemical product.

Microbes

Tiny organisms (including viruses and bacteria) that can be seen only with a microscope.

MMR vaccine

A vaccine against measles, mumps, and rubella.

Microenvironments

(Biology) the cells, molecules, and structures (such as blood vessels) that surround and support other cells and tissues.

Modified Release

Denoting a formulation of a medicinal drug taken orally that releases the active ingredients over several hours, in order to maintain a relatively constant plasma concentration of the drug.

Microfluidics Modulation Spectroscopy (MMS)

An infrared spectroscopy technique that is used to characterize protein secondary structure with high sensitivity and throughput by integrating microfluidics and spectroscopy.

Macrophage

A large white cell that is highly specialized in removal of dying or dead cells and cellular debris via phagocytosis. It is also one of antigen presenting cells, meaning they can present peptides from phagocytosed antigens on their cell surface for activation of T helper cells.

Medical Legal Review (MLR)

Medical, legal, and regulatory affairs review. An essential process in healthcare marketing to make sure advertising and promotional content is accurate, compliant, and ready to be published.

Macule

Non-raised skin lesions, normally red-colored.

Medical Science Liaison (MSL)

A healthcare consulting professional who is employed by pharmaceutical, biotechnology, medical device, and managed care companies and build relationships with key opinion leaders or thought leaders and health care providers, providing critical windows of insight into the market and competition. Through such monitoring, they can gain access to key influencers by interacting with national and regional societies and organizations.

Malaria

A mosquito-borne infectious disease caused by single-celled microorganisms of the Plasmodium group. Symptoms typically include fever, fatigue, vomiting, and headaches. In severe cases, it can cause jaundice, seizures, coma, or death.

Memory cell

A group of cells that help the body defend itself against disease by remembering prior exposure to specific organisms such as viruses and bacteria. Consequently, these cells are able to respond quickly when these organisms repeatedly threaten the body.

Manufacture

All operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.

Meningitis

Inflammation of the membrane covering the brain and spinal cord.