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Absorption

In pharmacology and pharmacokinetics, absorption is the process whereby medicines are transported or taken up from the site of administration (by mouth, inhalation, intravenous or intramuscular injection, etc.) to the blood through capillary, osmotic, solvent, or chemical action in the cells. This could be through the intestinal wall, skin, or mucous membranes.

In specific situations, such as intravenous (IV) therapy, absorption is straightforward and there is less variability, because the medicine goes directly in to the bloodstream. In the case of IV injection, the bioavailability of the compound is 100%.

Absorption is a primary focus in medicines development, as a compound must first be absorbed before any medicinal effects can take place. Moreover, the medicine™s pharmacokinetic profile can be significantly changed by factors that affect absorption.

Absorption, Distribution, Metabolism, and Excretion

Absorption, Distribution, Metabolism, and Excretion

Acquired Immunodeficiency Syndrome

Acquired Immunodeficiency Syndrome (AIDS) is the group of conditions that develop during the advanced stage of  infection with the human immunodeficiency virus (HIV). People at this stage of HIV disease have badly damaged immune systems, which puts them at risk of infection. Patients frequently develop infections and tumours that do not usually affect people who have healthy immune systems.

Acquired Immunodeficiency Syndrome (AIDS)

Acquired Immunodeficiency Syndrome (AIDS) is the group of conditions that develop during the advanced stage of  infection with the human immunodeficiency virus (HIV). People at this stage of HIV disease have badly damaged immune systems, which puts them at risk of infection. Patients frequently develop infections and tumours that do not usually affect people who have healthy immune systems.

Active molecule

In medicines R&D an active molecule is a chemical compound that has pharmacological or biological activity likely to be therapeutically useful.

Active Pharmaceutical Ingredient


Adaptive Design

The option to modify the design of an ongoing clinical trial is becoming increasingly common and is known as adaptive design. Data are evaluated before the trial is finished. This is known as interim analysis and might be carried out at several time points. Depending on the circumstances, this may lead to changes to the trial such as stopping one treatment arm or changing the number of participants in a group. The planned number of participants might be reduced if the interim analysis shows that a smaller sample size will still allow a valid result to be obtained. Alternatively, the sample size might be increased if that will allow a valid or reliable result to be obtained within a more acceptable period of time.

Adaptive designs can save time and resources, and can reduce the exposure of study participants to the inferior treatment.

Interim analyses and any anticipated changes to a trial should be described and justified in the study protocol.

Adenovirus

Adenoviruses are medium-sized viruses. They cause a wide range of illnesses in the lungs, stomach, intestines, and eyes, from mild respiratory infections in young children to life-threatening multi-organ disease in people with a weakened immune system. Adenoviruses are used in research as vehicles for gene therapy and vaccines.

Adherence

In medicine, adherence describes the degree to which a patient correctly follows medical advice. Poor adherence is often associated with patients not following prescribed medicines and treatment regimes. Non-adherence or poor adherence has been reported as a major problem in medical practice and can also affect the outcomes of a clinical trial. Poor adherence, or failure to follow treatment instructions, may be attributed to a number of reasons such as poor communication, forgetfulness, or unpleasant side-effects.

Efforts to improve adherence in clinical practice have included simplifying medication packaging, providing medication reminders, improving patient education, and limiting the number of medications prescribed simultaneously. Various measures of adherence are used in clinical trials, for instance: the assessment of pharmacological response, electronic diaries, residual tablet count, devices to monitor tablet removal from containers, testing for medicine in blood or urine, or the use of pharmacological markers/indicators.

Adjuvant

An adjuvant is a substance (pharmacological and/or immunological) that modifies the effect of other substances or medicines. Immunological adjuvants may be added to vaccines to boost the immune response. Adjuvant therapy or care is therapy that is given in addition to the main or initial therapy to maximise its effectiveness. For example, radiotherapy is commonly given as adjuvant treatment after surgery for breast or other cancers.

Advanced therapy medicinal products

Advanced therapy medicinal products (ATMP) are new medical products for human use based on genes (gene therapy), cells (cell therapy), or tissues (tissue engineering). They have huge potential and open the way for new treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer's, cancer, or muscular dystrophy.

Adverse Drug Reaction

A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility.

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Adapted from the Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 3) 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf

Adverse event

Any untoward (not favourable) medical occurrence in a patient, or clinical trial participant receiving a medicine, and which does not necessarily have a causal relationship with this treatment.

Adverse events can therefore be: any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporallyassociated with the use of a medicine, whether or not considered related to the medicine.

Adverse reaction

An adverse reaction, is any adverse event or experience related to a medicine for which a reasonable causal relationship with the medicine™s use is suspected. This is synonymous with adverse drug reaction (ADR).

Aetiology

In medical science it is the study of the causes of diseases and the factors underlying their spread.

Agence Nationale de Sécurité du Médicament et des Produits de Santé


Agencia de Evaluación de Tecnologías Sanitarias


Agencia Española de Medicamentos y Productos Sanitarios


Agencija za lijekove i medicinske proizvode


Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale


Agentur für Gesundheit und Ernährungssicherheit


Agenzia Italiana del Farmaco


Agglomerate

Cluster of independent but similar things collected or formed into a mass.

Allocation concealment

A technique used to prevent selection bias by concealing the allocation sequence from those assigning participants to intervention groups, until the moment of assignment. Allocation concealment prevents researchers from (unconsciously or otherwise) influencing which participants are assigned to a given intervention group.

Taken from Consort http://www.consort-statement.org/resources/glossary

Allogeneic cells

Allogeneic cells are cells obtained from a donor, such as bone marrow or umbilical cord blood.

Alternative hypothesis

In medicines development one might for example formulate the hypothesis that a new treatment for a disease is better than the existing standard of care treatment. If the new treatment is called B™, and the standard of care treatment is called A™ then the hypothesis states that B™ is better than A™. This hypothesis would be referred to as the alternative hypothesis. It is also known as the research hypothesis™.

The concept of the alternative or research hypothesis is a central part of formal hypothesis testing.

One might presume that scientists would set about proving the alternative or research hypothesis (B is better than A), but that is not the case. Instead this objective is approached indirectly. Rather than trying to prove the alternative or research hypothesis, scientific method assumes that in fact B does not differ from A “ that the new treatment does not offer an improvement over the standard of care treatment. This is known as the null hypothesis.

In order to understand why scientific method adopts this indirect approach in hypothesis testing it may be useful to bear in mind what Albert Einstein said: No amount of experimentation can ever prove me right a single experiment can prove me wrong.™

So, scientists use statistical tests to determine if the null hypothesis is true or false. If they can show with a certain likelihood (probability) that the null hypothesis is false, then the alternative or research hypothesis would be adopted (must be true)

Ames test

The Ames test is a biological assay that uses bacteria to analyse whether a chemical can cause mutations in the DNA. A positive test indicates that the chemical is mutagenic and therefore may act as a carcinogen.

Amorphous

Having no definite or specific shape or form. Shapeless.

Amt für Gesundheit


Analysis of Variance

Analysis of Variance

Anonymise

The removal of personal information (such as names or addresses of clinical trial participants) so that people using trial data cannot identify the individuals who took part. Truly anonymised data contain no information that could reasonably be used, by anyone, to identify individuals - even by cross-checking  the data against other sources of information. Anonymous data are data that have had personal information removed.

Anonymous

Anonymous data has had all personal information (such as names or addresses of clinical trial participants) removed, so that people using trial data cannot identify the individuals who took part. Truly anonymised data contain no information that could reasonably be used, by anyone, to identify individuals “ even by cross-checking the data against other sources of information. Anonymous data are data that have had personal information removed.

Anonymous coding systems

Sets of data from individuals in a trial are given unique codes so they can be stored and managed properly. Anonymous coding systems (ACS) use codes that do not relate to personal information that might be used to identify the individual in any way (for example, a participant's initials or health record number must not be included in the code). This allows individuals taking part in clinical trials to remain anonymous.

Coding can be important to allow tracing of individuals in the future (for example to allow authorised health professionals to follow up on results that come out of trials). To enable this, information about which individual was given which code is usually held securely, for example at a separate location not involved in the trial.

Anthropology

The scientific study of the social, cultural and physical development of humans, past and present.

Antibody

An antibody (AB), also known as an immunoglobin, is a protein produced by the body's immune system when it detects harmful substances (called antigens). Antigens can be molecules from microorganisms (bacteria, fungi, parasites, and viruses), or chemicals (insect venom). Antibodies recognise and latch onto antigens in order to neutralise them.

Antibody-Drug Conjugates

Antibody-Drug Conjugates

Antigen

The part of a pathogen that stimulates a response from the immune system.

Area Under the Curve

In the field of pharmacokinetics, the Area Under the Curve (AUC) has a specific meaning. It is the region under a plotted line in a graph of medicine concentration in blood plasma over time. Typically, the area is calculated starting from the time the medicine is administered until the time when the concentration in plasma is insignificant. The area under the curve represents the total exposure that the body receives to an active substance, and helps to evaluate and compare bioavailability profiles between medicines. The time at which the highest concentration of the active substance is found in the blood is called Tmax, and the maximum concentration of the active substance found in the blood stream is called Cmax.

Arm

In clinical research this refers to any of the treatment groups in a randomised trial. Many randomised trials have two ˜arms™ or groups, but some may have three or even more.

Attrition

Attrition is the loss of participants during a clinical trial it is also known as the 'drop-out rate'. The opposite of attrition is 'retention'.

Attrition can cause bias in study results if more participants drop out of one study arm than another, or if there is a difference between the participants who drop out and those who continue. Attrition can affect how applicable the results of a study are (external validity), or the statistical power of a study.

Research suggests that using a combination of strategies can improve the retention of participants in trials. Many different methods may be appropriate, for example providing incentives for taking part, giving personal reminders of appointments, and involving patients and/or their carers throughout the trial-design process.

Audit

Audits (independent evaluations of activities, processes and product quality) are an element of quality management in industry, finance, commerce and public service. They are typically performed by an independent auditing service, but may also be conducted as an internal audit (self-inspection) by the company through a specific audit department usually directly reporting to the board.

In medicines development, two audit types are routine and required:

1) Good Manufacturing Practice (GMP) audits (self-inspections) to monitor the implementation and compliance with good manufacturing practice principles (required as per Directive 2003/94/EC) and other quality standards like ICH Q10 and to propose necessary corrective measures.

2) Good Clinical Practice (GCP) audits, a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data was recorded, analysed and accurately reported according to the protocol, sponsor™s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) (ICH E6 Directive 75/318/EEC as amended

Autologous

Autologous tissue or cells are tissue or cells derived from the same individual. For example, skin transferred from one part of the body to another is autologous tissue in advanced therapies, stem cells are removed, stored, and later given back to the same person. Autologous transplants are used to treat a number of different blood cancers. Autologous stem cell transplantation is distinguished from allogeneic stem cell transplantation, where the donor and the recipient of the transplanted stem cells are different people.

Autoridade Nacional do Medicamento e Produtos de Saúde



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