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PubMed2003

The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs.

BACKGROUND: For the purposes of drug approval, the interchangeability of a generic drug and the corresponding brand-name drug is based on the criterion of "essential similarity," which requires that the generic drug have the same amount and type of active principle, the same route of administration, and the same therapeutic effectiveness as the original drug, as demonstrated by a bioequivalence study. However, bioequivalence and therapeutic effectiveness are not necessarily the same. OBJECTIVE: This review summarizes available data comparing the bioequivalence and therapeutic efficacy of brand-name psychoactive drugs with those of the corresponding generic products. METHODS: Relevant information was identified through searches of MEDLINE, Current Contents/Clinical Medicine, and EMBASE for English-language articles and English abstracts of articles in other languages published between 1975 and the present. The search terms used were generic drug, branded drug, safety, toxicity, adverse events, clinical efficacy, bioequivalence, bioavailability, psychoactive drugs, and excipients. RESULTS: Few publications compared the bioequivalence and efficacy of brand-name and generic psychoactive drugs. Those that were identified revealed differences in the efficacy and tolerability of brand-name and generic psychoactive drugs that had not been noted in the original bioequivalence studies. Specifically, l study found that plasma levels of phenytoin were 31% lower after a switch from a brand-name to a generic product. Several controlled studies of carbamazepine showed a recurrence of convulsions after the shift to a generic formulation. After a sudden recurrence of seizures when generic valproic acid was substituted for the brand-name product, an investigation by the US Food and Drug Administration found a difference in bioavailability between the 2 formulations. Statistically significant differences in pharmacokinetic variables have been reported in favor of brand-name versus generic diazepam (P < 0.001). Finally, a case report involving paroxetine mesylate cast doubt on the tolerability and efficacy of the generic formulation. CONCLUSION: The essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects.

Anticonvulsants↗
PubMed2001

Influence of secretin and L-NAME on vascular permeability in the coronary circulation of intact and diabetic rats.

The permeability in the intact and diabetic rat coronary circulation after administration of secretin (3.0 micromol/kg i.v.), an inhibitor of NOS (nitric oxide synthase), and L-NAME (N(G)-nitro-L-arginine-methyl ester hydrochloride) (1 mg/kg i.v.), and both substances given together, were studied. To measure protein extravasation Evans blue dye was used as a marker of vascular permeability. The vascular permeability of the left ventricle did not differ in intact and diabetic rats. In the diabetes state increased permeability of atria was observed. Administration of secretin did not influence the coronary vascular permeability in either the intact or the diabetic rats. L-NAME increased the atria permeability and did not change left ventricle permeability. In diabetes, injection of L-NAME caused a decrease in the permeability in both the atria and left ventricle. In intact rats secretin diminished the L-NAME effect in the atria. In diabetic rats co-administration of secretin+L-NAME increased the permeability of the atria and left ventricle, but L-NAME administered alone decreased them. Secretin modified the effect of L-NAME on coronary permeability in intact and diabetic rats.

Animals↗
PubMed1985

A comparison of the effects of interspersal and concurrent training sequences on acquisition, retention, and generalization of picture names.

A comparison was made between an interspersal and a concurrent procedure in teaching picture names to three mentally handicapped children. During the interspersal procedure a picture thats name was being trained was alternated with pictures already known; during the concurrent procedure a picture thats name was being trained was alternated with other pictures thats names were unknown. An ABA design with counterbalancing (BAB) was used. The children learned naming responses more rapidly when trained by the interspersal procedure than by the concurrent procedure. Weekly retention tests on pictures learned to criterion during the week showed no consistent difference between the two procedures in percentage of learned picture names retained. Weekly generalization tests showed that picture names that were retained in both conditions tended to generalize equally to a different setting and tester, and to the objects depicted in the pictures.

Child↗
PubMed1999

No fathers' names: a risk factor for infant mortality in the State of Georgia, USA.

Many studies have explored maternal and infant factors as risks for infant mortality, but little attention is given to paternal factors. In Georgia, listing a father's name on the birth certificate is optional for married couples and possible after paternal acknowledgment for unmarried couples. The authors evaluated father's name reporting as a paternity measure and risk for infant mortality. Using the linked 1989-1990 birth and death certificates of singleton Georgia infants to calculate relative risks (RRs), infant mortality rates for 38,943 infants with no father's names listed were compared to rates for 178,100 with father's names listed. Compared with the rate for married women listing names, the death rates were higher for unmarried mothers not listing fathers (relative risk, RR = 2.5; 95% CI 2.3-2.7), unmarried mothers listing fathers (RR = 1.4; 95% CI 1.3-1.6), and married women not listing fathers (RR = 2.3; 95% CI 1.6-3.1). Increased risks remained after stratifying by maternal race, age, adequacy of prenatal care and medical risks; and congenital malformations, birthweight, gestational age, and small-for-gestational age. Using logistic regression to examine for effect modification and to adjust for these factors together, the adjusted relative risks for death varied across different groups without fathers' names, regardless of marital status. For example, it remained statistically higher for infants with no father listed and without effect-modifying conditions such as low birthweight (estimated RR = 2.0; 95% CI 1.6-2.4). Although these findings suggest paternal involvement, as measured by listing fathers' names, is protective against low birthweight and infant mortality, further evaluation is needed.

Adolescent↗
PubMedDate not supplied

Visual and auditory naming in patients with left or bilateral temporal lobe epilepsy.

Impairment on visual naming tests is relatively common among temporal lobe epilepsy (TLE) patients. Recent reports suggested that the ability to name objects on the basis of their descriptions is an even more sensitive and perhaps more ecologically valid measure of naming problems among left hemisphere TLE patients. To further explore the nature of dysnomia in TLE, the current study assessed a group of patients with either left or bilateral TLE (n=16) and a group of healthy controls (n=11) on computerized measures of naming to description or auditory naming (AN) and visual naming (VN). Both speed and accuracy scores on AN distinguished patients from controls better than VN scores. There was a trend for AN speed, but not other naming test variables, to be associated with self-reported word finding problems. AN speed and accuracy, but not VN scores, correlated significantly with a broad range of other cognitive test scores. In summary, AN speed and accuracy are sensitive indexes of cognitive dysfunction in TLE patients. AN may be an appropriate analogue of the word finding demands of conversational speech because of its multiple neuropsychological demands. These results provide further evidence of the potential value of AN assessment in TLE patients. Further study of the cognitive processes required during AN, its relation to word finding problems in discourse, and the effect of anterior temporal lobectomy on this ability is warranted.

Adult↗
PubMed2004

Neurophysiologic correlates of deficient phonological representations and object naming in prematurely born children.

OBJECTIVE: The aim of this follow-up study was to evaluate the development of object naming ability and auditory processing in prematurely born children. Furthermore, we investigated whether the mismatch negativity (MMN) parameters at the age of 4 years correlate with the MMN parameters and naming ability at the age of 6 years. METHODS: Twelve very low birth weight (VLBW) preterm children (mean age 5 years 7 months) and matched controls were studied. Object naming was measured by the Boston naming test. Auditory event-related potentials (ERPs), especially the MMN, were recorded for Finnish syllables (standard /taa/; deviants /ta/ and /kaa/) in an oddball paradigm. RESULTS: VLBW preterm children scored significantly lower in the object naming test than their controls. The MMN amplitude for consonant change was significantly smaller in the preterm group compared to the controls. The MMN amplitude at the age of 4 years correlated with the MMN amplitude at the age of 6 years. Furthermore, absence of the MMN at the age of 4 years predicted naming difficulties at the age of 6 years. CONCLUSIONS: VLBW preterm children with a difficulty to preattentively discriminate changes in syllables, as indexed by the diminished change detection response, MMN, seem to have sustained naming difficulty. Therefore, it is reasonable to record the MMN along with the language development from infancy, in order to identify the children at risk for language deficiencies and to provide appropriate rehabilitation.

Auditory Perception↗
PubMed1999

A differential brain response to the subject's own name persists during sleep.

METHODS: Auditory evoked potentials (AEPs) to the subject's own name and to seven other first names were recorded in ten normal adults during wakefulness, in both passive listening and active detection conditions, and during sleep stage II (SII) and paradoxical sleep (PS). All stimuli were disyllabic, equiprobable and presented in random order. RESULTS: During wakefulness, a parietal positive 'P3' component, peaking at about 500 ms, probably equivalent to the endogenous P300 wave, was enhanced in response to the subject's own name, even in the passive condition. During SII, K-complexes (KCs) were evoked by all first names and were formed by two biphasic consecutive waveforms. While the amplitude of the late complex (N3/P4) was identical for both types of stimuli, the early portion of the KC (N2/P3), and notably the positive wave 'SII-P3' at about 600 ms, was selectively enhanced after the subject's own name. This supports the hypothesis that at least two distinct neuronal systems are activated in parallel in response to auditory stimuli during SII, one reflecting the detection of stimulus' salience and the other the processing of its intrinsic relevance. During PS, the AEP morphology was comparable to that observed in wakefulness. Notably, a posterior 'PS-P3' wave appeared exclusively in response to own names at about 550 ms, and was considered as an equivalent of the waking P300. CONCLUSIONS: These results suggest that the sleeping brain, during SII and PS, elicits a differential cognitive response to the presentation of the subject's own name, comparable to that occurring during wakefulness, and therefore that the sleeping brain is able to detect and categorize some particular aspects of stimulus significance.

Acoustic Stimulation↗
PubMed1998

Phonological naming therapy in jargon aphasia: positive but paradoxical effects.

This article is a single-case investigation of phonological naming therapy. The individual involved had fluent jargon speech, with neologisms, verbal paraphasias, and paragrammatisms. The jargon was underpinned by a severe anomia. Content words were rarely accessed either in spontaneous speech or naming. Single word investigations highlighted some preserved skills. Auditory comprehension, at least for concrete words, was relatively intact and although nonwords could not be repeated, words could, and at a level which was far superior to naming. The patient also had some ability to respond to phonological cues. These results suggested that phonological representations were preserved and that there were some intact semantic abilities. It seemed that the naming disorder was primarily due to an inability to access phonology from semantics. Therapy took a phonological approach. The patient was encouraged to reflect upon the syllabic structure and first phoneme of pictured targets. Subsequently, she was required to use this partial phonological knowledge as a self-cue. It was hypothesized that this therapy might equip the subject with a self-cuing naming strategy. Posttherapy investigations of naming demonstrated dramatic improvements, which generalized to untreated items. However, there was little evidence that these were due to a self cuing strategy. Performance on phonological judgment and discrimination assessments, which required conscious phonological reflection, was unchanged, and there were no signs that the patient was self-cuing during naming. Reasons for these paradoxical results are discussed.

Anomia↗
PubMed2001

Etiology of reading difficulties and rapid naming: the Colorado Twin Study of Reading Disability.

Children with reading deficits perform more slowly than normally-achieving readers on speed of processing measures, such as rapid naming (RN). Although rapid naming is a well-established correlate of reading performance and both are heritable, few studies have attempted to assess the cause of their covariation. Measures of rapid naming (numbers, colors, objects, and letters subtests), phonological decoding, orthographic choice, and a composite variable (DISCR) derived from the reading recognition, reading comprehension, and spelling subtests of the Peabody Individual Achievement Test were obtained from a total of 550 twin pairs with a positive school history of reading problems. Basic DeFries and Fulker (DF) multiple regression models for the analysis of selected twin data confirmed the heritable nature of phonological decoding, orthographic choice, DISCR, and rapid-naming composites. Bivariate DF models were employed to examine the extent to which deficits in the three reading-related measures covary genetically with rapid naming. Significant bivariate heritability estimates for each of the reading measures with the numbers and letters rapid-naming composite were also obtained. As expected, univariate sib-pair linkage analyses indicated the presence of a quantitative trait locus (QTL) on chromosome 6p21.3 for phonological decoding and orthographic choice deficits. Bivariate linkage analyses were then conducted to test the hypothesis that this QTL for reading difficulties is pleiotropic for slower performance on RN tasks. The results obtained from these analyses did not provide substantial evidence that the 6p QTL for reading difficulties has significant effects on rapid naming; however, larger samples would be required to test this hypothesis more rigorously.

Adolescent↗
PubMed2006

Syllabic priming effects in picture naming in French: lost in the sea!

Ferrand, Segui, and Grainger (1996) found robust syllable priming effects in picture naming latencies: Pictures primed with their initial syllable (e.g., ba for baleine [whale]) were processed faster than pictures primed with a string of letters shorter or longer than their initial syllable (e.g., bal for baleine). However, in several studies, these priming effects have not been replicated in word naming or in picture naming either in Dutch or in English (Schiller, 1998, 1999, 2000). The present study was aimed at replicating syllable priming effects in picture naming in French using a masked priming paradigm. The study employed a larger number of participants and items than were used in the Ferrand et al. (1996) study. The syllable priming effect in picture naming latencies was not replicated. Subsampling procedures were then used to examine the stability of the Ferrand et al. (1996) pattern of results in picture naming in greater detail. The syllabic priming effect in picture naming turned out to be an extremely rare event.

Adolescent↗
PubMed2006

Impaired naming of unique landmarks is associated with left temporal polar damage.

Previous studies have shown that the left temporal polar (TP) region is important for the retrieval of proper names for persons. It has been proposed that the key specialization of left TP is for proper nouns (rather than names for persons, per se), which predicts that left TP should support other categories whose members are denoted by proper names (e.g., landmarks). A lesion study tested the hypothesis that impaired naming of famous unique landmarks would be associated with damage to left TP. A Landmark Recognition and Naming Test was administered to participants with lesions to left TP, right TP, or regions outside TP. The results provided strong support for the hypothesis: Landmark naming was significantly inferior in the left group, supporting the hypothesis. The findings converge with previous lesion and functional imaging data to support the idea that the left TP region is important for the retrieval of names for unique entities. This fits the proposal that left TP contains convergence regions that operate as intermediaries between conceptual knowledge retrieval and lexical retrieval for classes of unique stimuli (H. Damasio, D. Tranel, T. J. Grabowski, R. Adolphs, & A. R. Damasio, 2004).

Adult↗
PubMed2006

Action and object naming in frontotemporal dementia, progressive supranuclear palsy, and corticobasal degeneration.

Action naming has been reported to be disproportionately impaired in comparison to object naming in patients with frontotemporal dementia (FTD). This finding has been attributed to the crucial role of frontal cortex in action naming. The investigation of object and action naming in the different subtypes of FTD, as well as in the related conditions of progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD), may thus contribute to the elucidation of the cerebral correlates of the action-object discrepancy as well as provide clues to the underlying cognitive mechanisms. The results indicated that, with the exception of semantic dementia, action naming was more impaired than object naming in all patient groups. The discrepancy was similar in frontal variant of FTD and Alzheimer's disease patients, whereas patients with nonfluent primary progressive aphasia, PSP, and CBD were significantly more impaired in the oral production of actions than of objects. These findings indicate that action naming impairment is not a general feature of FTD, but rather is associated with conditions that affect the frontoparietal-subcortical circuits involved in action knowledge and action representation.

Aged↗
PubMed2000

Ordinal knowledge: number names and number concepts in Chinese and English.

Previous research has demonstrated cross-language variation in early counting associated with linguistic differences in number-naming systems. Ordinal number names are typically learned later than cardinal names, but languages also differ in the regularity with which they form these names. Elementary school children in China and the U.S. showed differences in the acquisition and use of ordinal numbers corresponding to linguistic differences in ordinal names in their native languages. On tasks assessing children's conceptual knowledge of ordinal relations, a more complicated picture emerged. These results suggest that (a) children induce their language's set of ordinal number names by generalization based on rules sanctioned by early examples, and (b) the relation between ordinal names and ordinal concepts is a complex one, with language only one source of difficulty in understanding ordinal relations. Implications for studies of the relation between linguistic structure and cognitive development are discussed, in particular the possibility that effects of linguistic differences may vary for different levels of development and for different aspects of cognition.

Child↗
PubMed1997

Comparative effects of L-NOARG and L-NAME on basal blood flow and ACh-induced vasodilatation in rat diaphragmatic microcirculation.

1. The effects of N omega-nitro-L-arginine (L-NOARG) and N omega-nitro-L-arginine methyl ester (L-NAME) on diaphragmatic microcirculation in male Sprague-Dawley rats were assessed under basal conditions and after acetylcholine (ACh) stimulation. In addition, L-arginine (L-arg) was used with the aim of preventing L-NOARG and L-NAME from inhibiting ACh-induced vasodilatation, in order to explore the possibility that L-NOARG is not only a nitric oxide (NO) synthase inhibitor but also a muscarinic receptor antagonist. 2. Male Sprague-Dawley rats were anaesthetized with urethane and mechanically ventilated. The left hemi-diaphragm of each rat was prepared and microvascular blood flow was recorded during continuous superfusion with bicarbonate-buffered prewarmed Ringer solution by using laser-Doppler flowmetry. The drugs were topically applied to the surface of the hemi-diaphragm. 3. Baseline microvascular blood flow was unaffected after 15 min superfusion with any one of the following agents: L-NOARG (0.1 mM). L-NAME (0.1 mM), L-arg (10 mM). 4. ACh (0.03 mM, 0.1 mM and 0.3 mM) elicited a significant increase of microvascular blood flow (171 +/- 16%, 214 +/- 55%, and 323 +/- 68% of baseline values, respectively), via interaction with the muscarinic receptor, for the vasodilator response was severely inhibited by 15 min superfusion with atropine (0.3 mM). 5. Following 15 min superfusion with either of the L-arg analogues (0.1 mM), the ACh-induced vasodilator response was significantly inhibited. Pretreatment with L-arg (10 mM) for 5 min, followed by co-administration of L-arg (10 mM) and L-NOARG (0.1 mM) for another 15 min significantly prevented the inhibitory effect of L-NOARG or ACh-induced vasodilatation. However, a similar pretreatment schedule with L-arg failed to prevent L-NAME from exerting its inhibitory effect. 6. Neither of the L-arg analogues potentiated sodium nitroprusside (10 microM and 30 microM)-induced vasodilatation. However, adenosine (0.1 mM)-induced vasodilatation was slightly but significantly attenuated by either L-NOARG (0.1 mM) or L-NAME (0.1 mM), an effect which was prevented by L-arg (10 mM). 7. In conclusion, an increase in endothelium-dependent blood flow stimulated by ACh may occur in diaphragmatic microcirculation of anaesthetized rats independently of low baseline NO activity. The results also suggest that L-NAME has muscarinic receptor antagonist action in addition to its ability to inhibit NO synthase. Thus, we suggest that L-NAME should not be used as a specific NO synthase inhibitor in the rat diaphragm in situations in which there is potential for muscarinic receptors to be stimulated.

Acetylcholine↗
PubMed1982

The acquisition of personal pronouns and proper names by an identical twin pair.

Twins have been reported to suffer both identity confusion and language delay as a result of their twinship. Evidence for such difficulties was sought by studying the acquisition of personal pronouns and naming conventions in one pair of identical twin boys from age 2:1 to 2:10. The twins' acquisition of personal pronouns was in accordance with nontwin norms. Their apparent delay in conventional proper name use was attributed to the invention of the word Gaga as a referent for self and other twin. As proper name use emerged, Gaga use declined, whereas personal pronouns remained relatively independent. We concluded that the twins gave no evidence of either an identity confusion or a genuine delay in naming. Rather, the difference in the acquisition of names between these twins and nontwins was the additional step of first naming the twinship before naming each twin, which nontwins would not have a reason to do.

Child Language↗
PubMed1983

Picture naming in language-impaired children.

A picture-naming task was used to examine word-finding problems in language-impaired children. The subjects included 20 language-impaired children, 20 normal children matched to the language-impaired children for chronological age, and 20 normal children matched to the language-impaired children on a composite index of language age. Children were shown 64 pictures of objects and asked to name each as rapidly as possible. The principal findings were that (a) pictures of objects with more frequently occurring names were named more rapidly than pictures of objects with less frequently occurring names; (b) language-imparied children named pictures less rapidly than their chronological-age peers but more rapidly than their language-age peers; and (c) the effects of frequency of occurrence on naming time were comparable for all three groups of children. Factors that may have accounted for the findings are discussed.

Child↗
PubMed1996

Why do children with specific language impairment name pictures more slowly than their peers?

To examine the role of different cognitive processes in accounting for the slower naming times of children with specific language impairment (SLI) relative to peers with no language impairment (NLI), three tasks designed to stress different types of processing, were administered: naming pictures with the signal to respond presented at various delay intervals, naming following different durations of exposure to identical and unrelated primes, and vocally responding to nonlinguistic stimuli. Children with SLI, aged 4 to 9.5 years, were significantly slower than their NLI age peers on naming and on responding to nonlinguistic stimuli, but the effect of delay interval before naming and of duration of prime exposure before naming was similar for both groups. Results suggested that speed of naming is related to the slower nonlinguistic response processing of children with SLI and not to speed of their linguistic or perceptual processing. To examine differences in processing that might relate to pattern of language performance we examined responses of two subgroups of SLI. The subgroup of children whose language problems involved expressive but not receptive skills was not significantly slower than their NLI peers. The children whose problems involved both expressive and receptive language were significantly slower, but this was influenced by age. Findings are discussed in terms of language performance, age, task variables, and a generalized rate-limiting factor.

Child↗
PubMed1998

Learning people's names following severe closed-head injury.

Although problems remembering people's names rank highly among the subjective complaints of patients with closed-head injuries, very few studies have examined their memory for people's names by objective measurements. An experiment is reported in which patients with severe closed-head injuries and normal controls learned the same set of words, either as names or as possessions, for unfamiliar faces. Name learning proved to be impaired in the patients. Patient recall of meaningless names and possessions which were described by nonwords was equally poor. The patients, but not the controls, recalled significantly fewer names than possessions if these items were described by concrete nouns. This last finding suggests that the patients' problems with learning people's names can not be fully explained by a general verbal learning impairment.

Adult↗