Clinical trialClinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.
ToxicologyToxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants. The relationship between dose and its effects on the exposed organism is of high significance in toxicology. Factors that influence chemical toxicity include the dosage, duration of exposure (whether it is acute or chronic), route of exposure, species, age, sex, and environment.
Aquatic toxicologyAquatic toxicology is the study of the effects of manufactured chemicals and other anthropogenic and natural materials and activities on s at various levels of organization, from subcellular through individual organisms to communities and ecosystems. Aquatic toxicology is a multidisciplinary field which integrates toxicology, aquatic ecology and aquatic chemistry. This field of study includes freshwater, marine water and sediment environments.
Clinical study designClinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration).
Case seriesA case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, or examines their medical records for exposure and outcome. Case series may be consecutive or non-consecutive, depending on whether all cases presenting to the reporting authors over a period were included, or only a selection. When information on more than three patients is included, the case series is considered to be a systematic investigation designed to contribute to generalizable knowledge (i.
Randomized controlled trialA randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled.
Preclinical developmentIn drug development, preclinical development, also termed preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals. The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and diagnostics.
Risk managementRisk management is the identification, evaluation, and prioritization of risks (defined in ISO 31000 as the effect of uncertainty on objectives) followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.
Evaluation strategyIn a programming language, an evaluation strategy is a set of rules for evaluating expressions. The term is often used to refer to the more specific notion of a parameter-passing strategy that defines the kind of value that is passed to the function for each parameter (the binding strategy) and whether to evaluate the parameters of a function call, and if so in what order (the evaluation order). The notion of reduction strategy is distinct, although some authors conflate the two terms and the definition of each term is not widely agreed upon.
Gender studiesGender studies is an interdisciplinary academic field devoted to analysing gender identity and gendered representation. Gender studies originated in the field of women's studies, concerning women, feminism, gender, and politics. The field now overlaps with queer studies and men's studies. Its rise to prominence, especially in Western universities after 1990, coincided with the rise of deconstruction.
