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The Journal of Clinical Psychiatry Sep 2015Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate...
Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy or development of drug-related adverse effects if these generics are interchanged in stable patients. In a recent study involving 292 indirect comparisons of generic formulations of 9 different drugs, mathematical modeling showed that in most cases (87.0% for maximum concentration, 90.1% for area under the curve, and 80.5% for both) generic drugs are bioequivalent to each other. These reassuring findings notwithstanding, prudence dictates that, in stable patients, generic drugs should be interchanged only if there is a good reason for it. This is because bioequivalent brands of drugs may differ in their excipient content, and this can result in variations in safety profiles.
Topics: Drugs, Generic; Excipients; Humans; Therapeutic Equivalency
PubMed: 26455677
DOI: 10.4088/JCP.15f10300 -
PLoS Genetics Aug 2020
Topics: Drug Development; Drug Industry; Drugs, Generic; Genetic Diseases, Inborn; Humans
PubMed: 32817613
DOI: 10.1371/journal.pgen.1008889 -
Neurobiology of Learning and Memory Nov 2020Memory-based cognition depends on both the ability to remember specific details of individual experiences and the ability to combine information across experiences to... (Review)
Review
Memory-based cognition depends on both the ability to remember specific details of individual experiences and the ability to combine information across experiences to generalize and derive new knowledge. A hippocampal role in rapid encoding of specific events is long established. More recent research also demonstrates hippocampal contributions to generalization, but their nature is still debated. The current review provides an overview of hippocampal-based generalization in two lines of research-episodic inference and categorization-and discusses evidence for four candidate mechanisms and representational schemes that may underpin such generalization. We highlight evidence showing that the hippocampus contributes specific memories to generalization decisions, but also forms generalized representations that integrate information across experiences. Multiple views are currently plausible of how such generalized representations form and relate to specific memories. Future research that uses behavioral and neural indices of both generalization and specificity may help resolve between the candidate generalization mechanisms, with the possibility that more than one view of hippocampal-based generalization may be valid. Importantly, all views share the emphasis on the broader role of the hippocampus in cognition that goes beyond remembering the past.
Topics: Concept Formation; Generalization, Psychological; Hippocampus; Humans; Memory
PubMed: 33007461
DOI: 10.1016/j.nlm.2020.107317 -
European Journal of Dermatology : EJD Sep 2022Generic drugs may differ from brand-name drugs in nature and quantity of excipients. Hypersensitivity to generic drugs is a subject of growing importance given their key... (Review)
Review
Generic drugs may differ from brand-name drugs in nature and quantity of excipients. Hypersensitivity to generic drugs is a subject of growing importance given their key role in healthcare spending policies, however, a review of published data highlighted that relevant data is sparse. No scientific rationale has emerged for labelling patients allergic to all generic drugs, and hypersensitivity to generic drugs may rather be explored on a case-by-case basis. In the case of hypersensitivity without any change in medication, it is advisable to check for a switch from a brand-name to a generic drug, and if hypersensitivity to a generic drug is suspected, its composition must be checked.
Topics: Humans; Drugs, Generic; Hypersensitivity; Excipients; Product Labeling
PubMed: 36468717
DOI: 10.1684/ejd.2022.4291 -
ELife Apr 2019Electric fish are able to take what they have learnt about sensory processing in certain situations and apply it in other situations.
Electric fish are able to take what they have learnt about sensory processing in certain situations and apply it in other situations.
Topics: Animals; Electric Fish; Electric Organ; Generalization, Psychological; Learning; Neuronal Plasticity
PubMed: 30969171
DOI: 10.7554/eLife.46651 -
Journal of Experimental Psychology.... Nov 2022How individuals learn complex regularities in the environment and generalize them to new instances is a key question in cognitive science. Although previous...
How individuals learn complex regularities in the environment and generalize them to new instances is a key question in cognitive science. Although previous investigations have advocated the idea that learning and generalizing depend upon separate processes, the same basic learning mechanisms may account for both. In language learning experiments, these mechanisms have typically been studied in isolation of broader cognitive phenomena such as memory, perception, and attention. Here, we show how learning and generalization in language is embedded in these broader theories by testing learners on their ability to chunk nonadjacent dependencies-a key structure in language but a challenge to theories that posit learning through the memorization of structure. In two studies, adult participants were trained and tested on an artificial language containing nonadjacent syllable dependencies, using a novel chunking-based serial recall task involving verbal repetition of target sequences (formed from learned strings) and scrambled foils. Participants recalled significantly more syllables, bigrams, trigrams, and nonadjacent dependencies from sequences conforming to the language's statistics (both learned and generalized sequences). They also encoded and generalized specific nonadjacent chunk information. These results suggest that participants chunk remote dependencies and rapidly generalize this information to novel structures. The results thus provide further support for learning-based approaches to language acquisition, and link statistical learning to broader cognitive mechanisms of memory. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
Topics: Adult; Attention; Generalization, Psychological; Humans; Language; Language Development; Learning
PubMed: 35467930
DOI: 10.1037/xge0001207 -
BMJ (Clinical Research Ed.) Jun 2006Using generic simvastatin as first line could save £2bn over five years in England
Using generic simvastatin as first line could save £2bn over five years in England
Topics: Drug Costs; Drugs, Generic; Health Policy; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors
PubMed: 16763226
DOI: 10.1136/bmj.332.7554.1344 -
PloS One 2019Generic pharmaceuticals should have very little price dispersion. Economics' Law of One Price suggests that identical goods, in the absence of trade frictions and under...
Generic pharmaceuticals should have very little price dispersion. Economics' Law of One Price suggests that identical goods, in the absence of trade frictions and under conditions of free competition and price flexibility, should sell for the same price, and the FDA ensures that generics are identical. In this study, we examine whether generic pharmaceuticals indeed have the low price dispersion that theory predicts, and if not, whether the dispersion seen for pharmaceuticals used to treat neuropsychiatric conditions is substantially higher than that of other drugs. Such a difference may offer an explanation for the price dispersion seen: namely, a strategy that takes advantage of buyers' cognitive constraints and impaired ability to comparison shop. We thus assembled a list of generic pharmaceuticals and their prices using www.GoodRx.com, based on a convenience sample of the 5 most popular drugs for 10 common medical conditions listed there. Three neuropsychiatric diagnoses were used: Alzheimer's disease, depression and schizophrenia. Seven other diagnoses served as controls: asthma; diabetes mellitus-type II; high cholesterol; hypertension; osteoarthritis; osteoporosis; and urinary tract infection. For each drug, we identified the highest and lowest prices and calculated the mean, median and coefficient of variation (CV). We further calculated the ratios of the highest price to the median price and of the highest to lowest price. We found that the mean price CV was 43%. For neuropsychiatric drugs and controls, it was 61% and 35%, respectively. The mean high-to-median ratio was3.7 for neuropsychiatric drugs and 1.9 for controls. The mean high-to-low ratio was 5.9 for neuropsychiatric drugs and 2.8 for controls. In short, generic medications have high price dispersion, despite public availability of prices. Although our study did not examine why this price dispersion is present, the especially large high-to-low price ratio for neuropsychiatric medications suggests a strategy that exploits vulnerable patients.
Topics: Antipsychotic Agents; Commerce; Drug Costs; Drugs, Generic; Humans
PubMed: 31738807
DOI: 10.1371/journal.pone.0225280 -
Therapeutic Delivery Sep 2018
Topics: Drug Development; Drugs, Generic; Equivalence Trials as Topic; Guidelines as Topic; Humans; Therapeutic Equivalency
PubMed: 30189807
DOI: 10.4155/tde-2018-0047 -
Applied Health Economics and Health... Aug 2015Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and... (Review)
Review
Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.
Topics: Cross-Cultural Comparison; Developing Countries; Drugs, Generic; Health Policy; Humans; Internationality; Legislation, Drug; Therapeutic Equivalency; World Health Organization
PubMed: 26091708
DOI: 10.1007/s40258-014-0146-1