Administration routes: The different ways drugs are introduced into the body
Bioavailability: the fraction (percentage) of an administered dose of unchanged medicine that reaches the blood stream.
Pediatric dosage forms: Age-appropriate medicines for children. The drug products in the form in which they are marketed for use in children, with a specific mixture of active and inactive components, in a particular configuration (such as a pill) and apportioned into a particular dose.
Excipients: Components of the medication different from the active ingredient (substance responsible for the pharmacological effect). They are used to achieve the desired pharmaceutical form (capsules, tablets, solutions, etc.) and facilitate the preparation, preservation and administration of medications.
Swallowability: The quality of being swallowable (relatively easy to swallow).
Palatability: The quality of being tasty or acceptable in some other way to the mouth
Acceptance (Acceptability?): According to the EMA (European medicines Agency) it is the overall ability and willingness of the patient to use and its caregiver to administer the medicine as intended
Dose delivery device: Utensils like spoons, dosing cups, droppers, cylindrical spoons, and oral syringes used by parents and caregivers to measure and give liquid medications for children
Modified release: mechanism that allows a drug to be released late after you take it o for a longer period of time or to a specific target (part or organ) in the body.
Adult dosage forms for paediatric administration: When doctors and parents or caregivers manipulate an adult medicine to get a dose that can be used for a child, for example, by splitting a tablet to provide a smaller dose.
Medical procedures
Images: An imaging test allows doctors to see what’s going on inside your body. These images show how your insides look and work so that health care providers can see changes that may be caused by your disease.
Electrocardiography: This test records the electrical signals in your heart. It’s used to detect heart problems and monitor the heart’s status.
Electroencephalography: This test detects electrical activity in your brain. It is used diagnose epilepsy and other brain disorders.
Biopsy test: A medical procedure in which a sample of tissue from a part of the body is taken out to be looked at under a microscope. Blood test/Urinalysis/Stool test: Commonly used tests to evaluate your overall health and detect and manage a wide range of disorders and medical conditions.
Colonoscopy/Sigmoidoscopy: Medical exam to look at the inside of large intestine with a long, flexible tube with a light and small video camera on the end.
Clinical trial and Pre-clinical Research
Design
Phase: Clinical trials testing new drugs are divided into different steps, called phases. The drug development process will normally has 4 phases (called I, II, II and IV) and will take many years (a decade or longer).
Open label study: A type of study in which both the health providers and the patients are aware of the drug or treatment being given.
Randomization: This is a way to randomly assign each participant of the study to either the treatment group or the control group (like flipping a coin).
Observational study: In this kind of study investigators only “observe” and participants may receive diagnostic or other types of tests as part of their normal medical care, but they won’t be assigned to specific interventions or treatments.
Interventional study: It is a term used to describe clinical trials studying a treatment, drug or procedure.
Lifecycle of medicines
Pre-clinical research: Testing of a new drug, device or other any medical treatment in laboratory experiments or in animals before clinical trials may be performed in humans.
Pilot Study: The small scale preliminary study examining a new method or treatment.
Pivotal Study: It is usually a phase III study which presents the data that regulatory agencies use to decide whether or not to approve a drug. This kind of trial will generally be randomized, include sufficient number of subjects, and whenever possible, double-blind.
Double-blind: When patients and doctors don’t know which study medicine or treatment patients are getting until the end of the trial period.
Translational study (research?): the process by which the results of research done in the laboratory are used to develop new ways to diagnose and treat disease.
Cohort study: A research study that compares a particular outcome (such as stomach cancer) in groups of people who are alike in many ways but with with certain differences (for example, male doctors who drink alcohol compared with those who do not drink).
Expanded Access: also called “compassionate use,” a way for patients to gain access to experimental therapeutics before getting the final regulatory agency approval for use in humans.
Protocol: A detailed plan of the study: who can be in a study, for how long, and what will happen.
PK/PD: Pharmacokinetics (PK) can be described as the study of ‘how the body processes the drug’ (including the processes by which a drug is absorbed, distributed in the body, localized in the tissues, and eliminated), while Pharmacodynamics (PD) is the study of the effects of the drug on the body.
Bioequivalence: Term is used to refero the fact that a generic medicine is interchangeable with a innovative medicine from the point of view of quality, safety and efficacy. Bioequivalence studies are conducted to demonstrate that, in terms of therapeutic efficacy, the generic medicine is equivalent and interchangeable with the innovative medicine.
Investigational product
Comparator: A comparator drug/intervention/treatment is an already approved and licensed drug/intervention/treatment that is currently being used on the market in clinical practice.
Control group: In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if this works.
Device: An object that has a specific use. In medicine, wheelchairs, pumps, and artificial limbs are examples of devices.
orphan drug: A drug used to treat, prevent, or diagnose an orphan disease. An orphan disease is a rare disease or condition.
placebo: It’s a pill, liquid, or powder that has no active drug in it.
approved drugs: An approved drug is a preparation that has been validated for a therapeutic use by a ruling authority of a government.
dummy medication: a pill or substance that is given to a patient like a drug but that has no physical effect on the patient
active drug: A drug that has effects on the body.
Ethical/Regulatory
Risk-Benefit: A comparison between the risks of a situation and its benefits. For example, it can help patients determine if it is worth participating in a clinical trial or if the risks are too high.
Ethics Committee: It is an independent body made up of health professionals and non-health members who evaluate the ethics of a clinical study before participants can register.
Ethical principles: Ethical principles exist to protect the participants of a trial and to ensure the integrity of the research. Nowadays different codes and regulations exist.
Patients’ rights: Patient rights are the (legal and ethical) basic rules of conduct between patients and medical providers.
Safety
Adverse Event: It is a harm that occurs while a patient takes a medication, regardless of whether the medication is suspected to be the cause.
Toxicity: It describes the adverse effects of a drug that occur because the dose has risen above the therapeutic range, either unintentionally or intentionally. // The extent to which a drug is harmful.
Adverse Reaction: it is an unwanted or harmful reaction that occurs while a patient takes a medication under normal conditions and it is suspected to be related to the drug.
Long-term safety: It reflects the potential for chronic, cumulative dose effects of a drug. The long-term safety of a medicine is monitored and continuously evaluated once it has been launched and is being used in ‘real-life’ conditions.
Patient Involvement
Decision making: It is the process of identifying and selecting options (based on the values, preferences and beliefs of the person making the decision) to finally make a choice, that may or may not prompt action, like taking part in a clinical trial.
Engagement in Research: Involvement in the design, conduct and dissemination of research.
Participation: Taking part of something, like taking part of a clinical study.
Patient-reported Outcome Measures (PROMs): Questionnaires on health and quality of life that patients complete in order to monitor their progress. PROMs are like “self-reports” of patients and they are usually used in clinical trials to understand wether a treatment is working or not.
Patient’s diary: It is a tool used during a clinical trial to assess characteristics of patient’s disease, like symptom severity or quality of life. A patient diary can be also used to see if a patient takes the medication according to the treatment plan.
Lay summary: It is a summary of a research project that is written in a lay (and age-appropriate) language to explain complex ideas and scientific terms to people who do not have previous knowledge about that topic.
EPAR: Abbreviation of European public assessment report. According to the EMA (European Medicines Agency) EPAT is a set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information.
