The Infona portal uses cookies, i.e. strings of text saved by a browser on the user's device. The portal can access those files and use them to remember the user's data, such as their chosen settings (screen view, interface language, etc.), or their login data. By using the Infona portal the user accepts automatic saving and using this information for portal operation purposes. More information on the subject can be found in the Privacy Policy and Terms of Service. By closing this window the user confirms that they have read the information on cookie usage, and they accept the privacy policy and the way cookies are used by the portal. You can change the cookie settings in your browser.
2 Physicians engaged in clinical research must address the challenge to determine whether a potential new intervention represents an advance over current methods, whether the new intervention would avoid harms currently incurred, whether it would save lives currently lost. They face the dilemma between the rigorous demands of science necessary to accept the challenge and find the answer and the obligation...
3 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects.
2 Clinical drug development is often described as consisting of four temporal phases (phases I-IV) [1]. Phase I starts with the initial administration of an investigational drug into humans, whereas phase-II studies are conducted to explore therapeutic efficacy and phase-III studies to demonstrate or confirm therapeutic benefit of the drug. Phase-IV studies begin after drug approval. However, it is...
2 It is considered that the first properly controlled trial in history was performed by James Lind. This Scottish surgeon and ship’s doctor was the first who conducted a trial with an appropriately controlled design from a modern point of view. In 1747 when scurvy was a common disease among sailors James Lind administered different acidic substances to 12 sailors affected with scurvy to test who benefits...
3 Epidemiologists have used observational studies for a long time to explore effects of infectious and non-infectious exposures on health outcomes. Outstanding people who performed milestone epidemiological research include Ignaz Semmelweis (1818-65), William Farr (1807-83), John Snow (1813-58), or later Sir Richard Doll (1912-2005). They all gave examples of the classical epidemiological approach...
The success of antibiotic therapy depends on complex interplay between the administered drug, its mechanism of action, concentration at site of infection, and complexity or severity of infection. Therapeutic response to an anti-infective agent or its pharmacological effect is often associated with high variability in clinical situations. Pharmacokinetics (PK) and pharmacodynamics (PD) contribute to...
Microdosing came onto the scene with the first publication of data in 2003. Since this time the number of compounds where the pharmacokinetics observed at a microdose compared to a therapeutic dose has grown steadily. Based on current data in the public domain, there are 23 drugs where microdose and therapeutic dose pharmacokinetics can be compared. Of these, 84% scale within a factor of 2 for oral...
3 Classically, epidemiology is defined as the study of the causes and the consequences of diseases occurring in a certain population. However, in the recent years the scope of epidemiological research has become much boarder, including the research for optimal treatment approaches in both acute and chronic diseases and the determination of number of patients affected by a disease, the latter being...
The history of placebo goes back several centuries. These “dummy pills” have been used by healers and physicians worldwide, ignored by the official medical community
In it’s Chapter about “Principles of Clinical Pharmacology” Harrsion’s Textbook of Internal Medicine 2008 states that “drugs are the cornerstone of modern therapeutics” and that “drug therapy varies widely among individuals” [1]. These two statements set the stage for the discipline of Clinical Pharmacology (CP) which pursues two main goals: (1) an empirical description of conditions under which drug...
2 Historically, pharmaceutical therapy has been extraordinarily successful in combating and alleviating various diseases. Common life threatening diseases, most notably infections, have extremely satisfying therapeutic success rates and many serious diseases like diabetes mellitus or some forms of cancer have become chronic, stable diseases and do not lead to extreme shortages of life years any longer...
2 The role of drug regulatory agencies is to protect and promote public health. In everyday practice, this broad mandate translates into two distinct objectives: first, into an obligation to protect patients against ineffective or harmful drugs, and second, to protect patients against the consequences of untreated disease. The first objective results in a gatekeeper function and obliges regulators...
2 Reimbursing pharmaceuticals is considered, in most developed countries, an important part of delivering healthcare, be it by the state - or so-called “Beveridge Systems”, by private health insurance providers, or by independent, non-profit statutory institutions - the so-called “Bismarck” system [1, 2]. Notably, this has also been the case for Medicare in the USA due to the Medicare Prescription...
Set the date range to filter the displayed results. You can set a starting date, ending date or both. You can enter the dates manually or choose them from the calendar.