Pharmaceutical Publication Planning
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Pharmaceutical Publication Planning
Pharmaceutical publication planning is the activity of planning the dissemination of scientific and clinical data on a drug to healthcare professionals at scientific congresses and medical society meetings and in peer reviewed medical journals. Procedure Pharmaceutical publication planning involves developing a detailed plan that outlines the timely presentation of verified scientific and clinical data to appropriate types of healthcare professionals such as physicians, pharmacists, nurses, as a drug undergoes clinical trials and after it is marketed. Because of scientific and therapeutic advances, pharmaceutical publication planning has become a well-established and important function by pharmaceutical companies in order to educate healthcare professionals accordingly about new drugs and marketed drugs with new clinical uses or safety information. Within pharmaceutical companies, publication planning is usually overseen by medical or clinical affairs professionals. In this ef ...
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Drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insufflation (medicine), inhalation, drug injection, injection, smoking, ingestion, absorption (skin), absorption via a dermal patch, patch on the skin, suppository, or sublingual administration, dissolution under the tongue. In pharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect. A pharmaceutical drug, also called a medication or medicine, is a chemical substance used to pharmacotherapy, treat, cure, preventive healthcare, prevent, or medical diagnosis, diagnose a disease or to promote well-being. Traditionally drugs were obtained through extraction from medicinal plants, but more recently also by organic synthesis. Pharmaceutical drugs may be used ...
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Safety
Safety is the state of being "safe", the condition of being protected from harm or other danger. Safety can also refer to risk management, the control of recognized hazards in order to achieve an acceptable level of risk. Meanings There are two slightly different meanings of ''safety''. For example, ''home safety'' may indicate a building's ability to protect against external harm events (such as weather, home invasion, etc.), or may indicate that its internal installations (such as appliances, stairs, etc.) are safe (not dangerous or harmful) for its inhabitants. Discussions of safety often include mention of related terms. Security is such a term. With time the definitions between these two have often become interchanged, equated, and frequently appear juxtaposed in the same sentence. Readers unfortunately are left to conclude whether they comprise a redundancy. This confuses the uniqueness that should be reserved for each by itself. When seen as unique, as we intend here, ...
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Professional Development
Professional development is learning to earn or maintain professional credentials such as academic degrees to formal coursework, attending conferences, and informal learning Informal learning is characterized "by a low degree of planning and organizing in terms of the learning context, learning support, learning time, and learning objectives". It differs from formal learning, non-formal learning, and self-regulated l ... opportunities situated in practice. It has been described as intensive and collaborative, ideally incorporating an evaluative stage. There is a variety of approaches to professional development, including consultation, coaching, community of practice, communities of practice, lesson study, mentoring, reflective supervision and technical assistance.National Professional Development Center on Inclusion. (2008)"What do we mean by professional development in the early childhood field?" Chapel Hill: The University of North Carolina, FPG Child Development Institute. ...
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Medical Research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientific principles that may apply to a ''preclinical'' understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine. Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term ''clinical trial''. However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics, medical devices, and non-pharmaceutical therapies means that pharmaceutical research i ...
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The International Publication Planning Association
''The'' () is a grammatical article in English, denoting persons or things that are already or about to be mentioned, under discussion, implied or otherwise presumed familiar to listeners, readers, or speakers. It is the definite article in English. ''The'' is the most frequently used word in the English language; studies and analyses of texts have found it to account for seven percent of all printed English-language words. It is derived from gendered articles in Old English which combined in Middle English and now has a single form used with nouns of any gender. The word can be used with both singular and plural nouns, and with a noun that starts with any letter. This is different from many other languages, which have different forms of the definite article for different genders or numbers. Pronunciation In most dialects, "the" is pronounced as (with the voiced dental fricative followed by a schwa) when followed by a consonant sound, and as (homophone of the archaic ...
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International Society Of Medical Publication Professionals
International is an adjective (also used as a noun) meaning "between nations". International may also refer to: Music Albums * ''International'' (Kevin Michael album), 2011 * ''International'' (New Order album), 2002 * ''International'' (The Three Degrees album), 1975 *''International'', 2018 album by L'Algérino Songs * The Internationale, the left-wing anthem * "International" (Chase & Status song), 2014 * "International", by Adventures in Stereo from ''Monomania'', 2000 * "International", by Brass Construction from ''Renegades'', 1984 * "International", by Thomas Leer from ''The Scale of Ten'', 1985 * "International", by Kevin Michael from ''International'' (Kevin Michael album), 2011 * "International", by McGuinness Flint from ''McGuinness Flint'', 1970 * "International", by Orchestral Manoeuvres in the Dark from '' Dazzle Ships'', 1983 * "International (Serious)", by Estelle from '' All of Me'', 2012 Politics * Political international, any transnational organizati ...
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Ethics
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns matters of value; these fields comprise the branch of philosophy called axiology. Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. As a field of intellectual inquiry, moral philosophy is related to the fields of moral psychology, descriptive ethics, and value theory. Three major areas of study within ethics recognized today are: # Meta-ethics, concerning the theoretical meaning and reference of moral propositions, and how their truth values (if any) can be determined; # Normative ethics, concerning the practical means of determining a moral course of action; # Applied ethics, concerning what a person is obligated (or permitted) to do ...
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Medical Writing
A medical writer, also referred to as medical communicator, is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical Document. The medical writers also ensure that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure. Medical writing as a function became established in the pharmaceutical, medical device industry and Contract Research Organizations (CROs) because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely. All new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This demand for the clear articulation of medical science, drives the demand for ...
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Media (communication)
In mass communication, media are the communication outlets or tools used to store and deliver information or data. The term refers to components of the mass media communications industry, such as print media, publishing, the news media, photography, Movie theater, cinema, broadcasting (radio and television), digital media, and advertising. The development of early writing and paper enabling longer-distance communication systems such as mail, including in the Achaemenid Empire, Persian Empire (Chapar Khaneh and Angarium) and Roman Empire, can be interpreted as early forms of media. Writers such as Howard Rheingold have framed early forms of human communication, such as the Lascaux, Lascaux cave paintings and early writing, as early forms of media. Another framing of the history of media starts with the Chauvet Cave paintings and continues with other ways to carry human communication beyond the short range of voice: smoke signals, Trail blazing, trail markers, and sculpture. The Te ...
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Biotechnology
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials ...
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Medical Writing
A medical writer, also referred to as medical communicator, is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical Document. The medical writers also ensure that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure. Medical writing as a function became established in the pharmaceutical, medical device industry and Contract Research Organizations (CROs) because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely. All new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This demand for the clear articulation of medical science, drives the demand for ...
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Clinical Significance
In medicine and psychology, clinical significance is the practical importance of a treatment effect—whether it has a real genuine, palpable, noticeable effect on daily life. Types of significance Statistical significance Statistical significance is used in hypothesis testing, whereby the null hypothesis (that there is no relationship between variables) is tested. A level of significance is selected (most commonly ''α'' = 0.05 or 0.01), which signifies the probability of incorrectly rejecting a true null hypothesis. If there is a significant difference between two groups at ''α'' = 0.05, it means that there is only a 5% probability of obtaining the observed results under the assumption that the difference is entirely due to chance (i.e., the null hypothesis is true); it gives no indication of the magnitude or clinical importance of the difference. When statistically significant results are achieved, they favor rejection of the null hypothesis, but they do not prove that the nul ...
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