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At least 109 records · Page 6Linked to original sources
PubMed2006

Prediction of drug-drug interactions for AUCoral of high clearance drug from in vitro data: utilization of a microtiter plate assay and a dispersion model.

The purpose of this study was to propose a new method to predict in vivo drug-drug interactions (DDIs) for a high clearance drug from in vitro data. As the high clearance drug, NE-100 (N, N-dipropyl-2-[4-methoxy-3-(2-phenylethoxy)phenyl]ethylamine monohydrochloride) was used. First, approach based on I(u)/K(i) value was used for the prediction of DDIs between NE-100 and concomitant drugs. When the K(i) values (K(i-cal)) obtained from the microtiter plate (MTP) assay and the reported K(i) values (K(i-rep)) for these drugs were used to predict increases at levels of NE-100 AUC(oral) (AUC(oral) ratio), the AUC(oral) ratios from the I(u)/K(i-cal) correlated with those from the I(u)/K(i-rep). This result suggests that the K(i-cal) from the MTP assay can be used for prediction of DDIs instead of the K(i-rep) value. Second, a new approach combining the inhibition rate (R) calculated from the MTP assay and two physiological models was used to predict DDIs. When the AUC(oral) ratios of NE-100 by various drugs were predicted using the R value and the well-stirred model, the ratios were similar to those predicted using the I(u)/K(i). However, after co-administration of drugs such as quinidine, propafenone and thioridazine (potent inhibitors of CYP2D6), the NE-100 AUC(oral) ratios predicted from the dispersion model was much greater than those from well-stirred model. This result shows that application of the dispersion model to the prediction method using the R value might sensitively and precisely predict the increased levels of AUC(oral) by DDIs for high clearance drug, compared with the prediction method using I(u)/K(i) value.

Administration, Oral↗
PubMedDate not supplied

Drug abundance: situation of drugs and drug distribution in the villages of rural Thailand.

The paper describes the situation of drugs and drug sources found available at the village level in Thailand. It concludes, from village-survey data (N = 195) and village case studies (N = 15), that drugs are available in abundance. A vast variety of drugs, including prescription drugs, are available at various sources, of which the most common ones are grocery stores. The situation reflects the failure of the drug regulation system as well as the influence of commercial pharmaceutical sector in drug provision. This situation hampers attempts to rationalize drug use by consumers.

Ambulatory Care Facilities↗
PubMed1996

Comprehensive drug screening in blood for detecting abused drugs or drugs potentially hazardous for traffic safety.

A comprehensive drug screening procedure for detecting drugs in the blood samples of car drivers suspected of driving under the influence of drugs, is presented. Amphetamines, cannabinoids, opioids, cocaine and benzodiazepines were screened by an immunological EMIT ETS system after acetone precipitation. Gas chromatographic methods were used to screen and quantitate basic, neutral and acidic drugs. The free amino groups of basic drugs were derivatized with heptafluorobutyric anhydride. Analysis was performed by a dual channel gas chromatograph combined with a nitrogen phosphorus and an electron capture detector. Phenyltrimethylammonium hydroxide was used as a methylathing agent for acidic substances before analysis with a gas chromatograph connected to a nitrogen phosphorus detector. A gas chromatograph/mass spectrometry was used as a common confirmation method. Tetrahydrocannabinol was quantitated after bis(trimethylsilyl)trifluoroacetamide derivatization, opiates after pentafluoropropionic anhydride derivatization and benzoylecgonine after pentafluoropropionic anhydride and pentafluoropropanol derivatization. Excluding benzodiazepines, which were confirmed with a gas chromatograph connected to a nitrogen phosphorus and an electron capture detector, the other basic drugs as well as the acidic drugs were confirmed after the same derivatization procedures as in the screening methods. Alcohols were quantitated in triplicate by gas chromatography using three different kinds of columns. Although urine is the most important specimen for screening abused drugs, it has only limited use in forensic toxicology. The described system is most useful for analyzing a wide range of substances, including illicit drugs, benzodiazepines, barbiturates, antidepressants and phenothiazenes in forensic samples when urine is not available.

Accidents, Traffic↗
PubMed1983

Drug effects on the liver. An updated tabular compilation of drugs and drug-related hepatic diseases.

Generic and chemical names of drugs and the possible adverse effects of these drugs on the human liver are tabulated. Most drugs compiled in these tables have been approved by the Federal Drug Administration. They are currently available in the United States, and they are listed in the 1983 Physicians' Desk Reference. Some important investigational drugs are listed also. The tables include: (1) generic names of drugs that have caused a characteristic morphologic change, such as granulomatous hepatitis; (2) morphologic diagnoses that have been documented after administration of each drug; and (3) references that can be matched to each drug and to its effects on the liver.

Carcinoma, Hepatocellular↗
PubMed1999

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to set forth procedures and requirements implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). The final rule sets forth requirements for the reimportation and wholesale distribution of prescription drugs; the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or health care entities, or donated to charitable organizations; and the distribution of prescription drug samples. FDA is also amending certain sections of the regulations entitled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors" to make them consistent with this final regulation.

Drug Industry↗
PubMed1993

[The incidence of drug side effects with reference to organ systems. Experience of the spontaneous reporting system of the Swiss Drug Side Effect Center and Comprehensive Drug Monitoring].

The reporting system of the Spontaneous Adverse Drug Reactions Center (SANZ) and the Comprehensive Hospital Drug Monitoring (CHDM) in Berne and St. Gallen are complementary ADR reporting institutions. The first collects data from the whole patient population as well as all drugs prescribed in Switzerland. The adverse drug reactions reported most frequently are easily detectable skin reactions, psychic disorders and reactions concerning the body as whole. From these reports signals can be generated, contributing to enhanced drug safety. The CHDM provides detailed information on all adverse drug reactions in a selected patient population. Because the number of patients exposed to a drug is known, a quantitative risk assessment can be calculated. The system contributes also to the detection of new ADRs. This relies partly on statistical analysis, partly on thorough clinical observations, but mostly on the combination of both. Allergic and pseudoallergic reactions were studied with some priority.

Adverse Drug Reaction Reporting Systems↗
PubMed1992

Nonsteroidal anti-inflammatory drug-associated pulmonary infiltrates with eosinophilia. Review of the literature and Food and Drug Administration Adverse Drug Reaction reports.

OBJECTIVE: The purpose of this study was to detail the clinical and pathologic presentation of pulmonary infiltrates with eosinophilia (PIE) associated with nonsteroidal anti-inflammatory drug use. METHODS: We reviewed case reports and Food and Drug Administration Adverse Drug Reaction Spontaneous Reporting Program reports. RESULTS: A case of pulmonary infiltrates with eosinophilia related to naproxen use was studied. Six similar cases from the medical literature and 22 reports from the Food and Drug Administration were reviewed. Four cases of PIE associated with ibuprofen, obtained from the Food and Drug Administration, and single literature reports of PIE associated with fenoprofen and sulindac detailed similar clinical presentations. The clinical presentation of PIE syndrome associated with nonsteroidal anti-inflammatory drugs included fever, cough, dyspnea, infiltrates on chest roentgenogram, and an absolute peripheral eosinophilia. Pathologic examination revealed poorly defined granulomas with infiltrating eosinophils. CONCLUSIONS: Naproxen and other nonsteroidal anti-inflammatory drugs can elicit the PIE syndrome. The prevalence of this side effect is likely underestimated, given the extensive use of these drugs and the relatively benign course of PIE syndrome.

Aged↗
PubMedDate not supplied

In vitro drug-drug interactions with perospirone and concomitantly administered drugs in human liver microsomes.

In vitro metabolism studies were conducted to assess drug-drug interactions between perospirone, an antipsychotic agent, and concomitantly administered drugs--biperiden, flunitrazepam, haloperidol, and diazepam--using human liver microsomes. The metabolism of perospirone in the presence of 100 microg/ml drugs was decreased to 45-73% of that in their absence, whereas no effects were observed with any of the drugs at 1 microg/ml or lower. The effects of perospirone on the metabolism of concomitantly administered drugs were also assessed, and no inhibitory effect was observed. Thus, the metabolism of perospirone and concomitantly administered drugs did not demonstrate any marked mutual inhibition in the human liver microsomes. On the other hand, the perospirone metabolism was markedly reduced by ketoconazole indicating a major role for CYP 3A4. Based on the inhibition constant (Ki) for perospirone metabolism and the plasma unbound concentration of ketoconazole, in vivo perospirone clearance was estimated to be reduced to 64-90% of the control level. Thus careful attention should be paid to the possibility of increase in unchanged perospirone concentration when perospirone is co-administered with drugs that are known as CYP3A4 inhibitors, including macrolide antibiotics and other imidazole antifungals.

Antifungal Agents↗
PubMed1993

Initiation into drug abuse: the pathway from being offered drugs to trying cannabis and progression to intravenous drug abuse.

The aim of the study was to analyse the initiation process into illicit drug use focusing on three endpoints which can be seen as stages in the drug career: being offered drugs, using cannabis and using intravenous drugs. Questionnaire data were available on 23,482 men, aged 18-20 years, conscripted for military service in 1969-70. The association between family background, social conditions, other illicit drug use, emotional control and the three endpoints were analysed. Although many conscripts tried cannabis, a smaller number continued with intravenous drug abuse. These were in general characterised by poor emotional control and a history of social maladjustment, and early onset of use. Our findings give further evidence for social maladjustment as a causative factor for illicit drug use and for the role of cannabis as a stepping stone to heavy drug abuse.

Adolescent↗
PubMed2006

Drug and medical cost effects of a drug formulary change with therapeutic interchange for statin drugs in a multistate managed Medicaid organization.

OBJECTIVE: Therapeutic interchange (TI) interventions are commonly used to manage pharmacy benefit costs. While several studies have considered the effect that TI interventions have on drug costs, most have not considered the effect they have on medical management costs. The purpose of the present study was to assess drug cost and drug therapy management costs of a TI intervention following a change in the drug formulary for 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) drugs, including the conversion of atorvastatin from formulary to nonformulary status. METHODS: A retrospective, quasi-experimental within-subjects design was used in this study. Administrative claims data were obtained from a select northeastern segment of a multistate Medicaid managed care organization (MCO). To be included in the study, patients had to meet the following criteria: (1) they must have had a minimum of 3 atorvastatin prescriptions during a 6-month enrollment phase, (2) they must have been continuously enrolled throughout the 900-day study period, and (3) they must have switched from atorvastatin to another statin between April 1, 2003, and July 31, 2003. The day of the switch from atorvastatin marked for each patient the end of the 12-month pre-TI period and the beginning of the 12-month post-TI period. Two separate dependent variables were developed: (1) statin drug costs (statin cost + dispensing fee) and (2) the costs paid by the MCO for the medical management of statin therapy, including office visit costs and the medical laboratory costs of measuring lipids and creatine kinase, and of checking liver functions. To estimate expenditures over 24 months, a panel analytic technique was used that allows each patient to serve as his or her own control. Multivariate models were used to assess the effects of the TI policy while controlling for age, gender, adjunctive dyslipidemia therapy, comorbidity, presence of a prior coronary artery event, statin compliance, cardiologist management, and disease severity. RESULTS: Of the 3,636 patients who met the study inclusion criteria and were converted from atorvastatin to an alternate statin drug, 129 patients (3.5%) switched back to atorvastatin following the TI. The average statin cost per claim in the 12-month post-TI period was Dollars 70.93, 9.5% less than the average cost in the 12-month pre-TI period (Dollars 78.40). The average cost per patient per year (PPPY) for statin laboratory tests (lipid panels, creatine kinase tests, and liver function tests) increased by 31.5% to Dollars 16.15 in the post-TI period compared with Dollars 12.28 PPPY in the pre-TI period, and medical office visit costs increased by 44.9% to Dollars 20.70 PPPY in the post-TI period compared with Dollars 14.29 PPPY in the preperiod. These increased costs related to the medical management of statin therapy were overwhelmed by an 11.7% reduction in statin drug costs, from Dollars 793.69 PPPY in the pre-TI period to Dollars 701.01 PPPY in the post-TI period, resulting in a net 10.0% reduction for combined statin costs and related medical costs, from Dollars 820.27 PPPY in the pre-TI period to Dollars 737.87 in the post-TI period. After limiting the analysis to patients who did not convert from atorvastatin to pravastatin (which cost more than atorvastatin before the rebate) and controlling for the influence of potential confounders, statin expenditure decreased by 33% (P < 0.001). Multivariate models indicated no statistically significant differences in the costs related to the medical management of statin therapy after the TI compared with before the TI.

Acyl Coenzyme A↗
PubMed2005

Extracting drug-drug interaction articles from MEDLINE to improve the content of drug databases.

Drug-drug interaction systems exhibit low signal-to-noise ratios because of the amount of clinically insignificant or inaccurate information they contain. MEDLINE represents a respected source of peer-reviewed biomedical citations that potentially might serve as a valuable source of drug-drug interaction information, if relevant articles could be pinpointed effectively and efficiently. We evaluated the classification capability of Support Vector Machines as a method for locating articles about drug interactions. We used a corpus of "positive" and"negative" drug interaction citations to generate datasets composed of MeSH terms, CUI-tagged title and abstract text, and stemmed text words. The study showed that automated classification techniques have the potential to perform at least as well as PubMed in identifying drug-drug interaction articles.

Algorithms↗
PubMed2005

Predicting drug-drug interactions in drug discovery: where are we now and where are we going?

Pressure on drug discovery research teams to identify successful drug candidates earlier on in the drug discovery process has led to the development of a variety of ADME in vitro assays, intended to guide chemists and biologists in their decision-making process. The role of these early assays is to indicate liabilities in scaffolds relating to the absorption, distribution, metabolism and cytochrome P450 (CYP) inhibition potential of new chemical entities. Current efforts in drug-drug interaction (DDI) screening can be divided into four basic categories: bioanalytical method development, strategies relating to enzyme kinetics, recognition of CYP allelic variants and generation of computational models to predict CYP interactions. Collectively, DDI screening represents an important means not only for assessing and ranking potential drug candidates, but also for aiding in the development of mechanisms for predicting and retrospectively explaining in vivo drug performance.

Animals↗
PubMed2003

Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.

The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes.

Drug Approval↗
PubMed2003

Does drug abuse beget drug abuse? Behavioral analysis of addiction liability in animal models of prenatal drug exposure.

Prenatal exposure to drugs of abuse is the single largest preventable cause of developmental compromise of American children today. In the clinical population, it is difficult to determine the independent effects of gestational exposure to a single drug on brain development, in part due to the confounding effects of additional risk factors that are encountered in the substance-abusing population. The enormous clinical and societal problem of gestational toxicity of drugs of abuse, both legal and illegal, has driven the need to develop and investigate animal models of gestational drug exposure in which these variables can be controlled. More specifically, as clinical data are gathered suggesting an increased liability to substance abuse among children of drug-abusing mothers, a mechanistic understanding of the lasting effects of early drug exposure on the developing brain and the behavioral repertoire of the developing animal is crucial. In this review we summarize experimental animal research that investigates the role of drug exposure in utero on the functional development of specific brain circuits that are involved in the reinforcing effects of drugs of abuse, and on the behaviors that are mediated by these brain reward systems.

Adult↗
PubMed1999

Drug network characteristics as a predictor of cessation of drug use among adult injection drug users: a prospective study.

Few studies have examined recovery from opiate and cocaine dependence without treatment, referred to as "natural recovery," "spontaneous recovery," and "spontaneous remission." The present study examined the relationship between network characteristics and cessation of heroin, cocaine, and crack use in a sample of underclass inner-city injection drug users in Baltimore, Maryland. Participants were enrolled in an experimental human immunodeficiency virus (HIV) preventive intervention. Between the baseline and follow-up interviews, which averaged 5.2 months, 24 (7%) of 335 participants reported ceasing to use heroin, cocaine, and crack. Individuals who had reported cessation of drug use at follow-up had reported at baseline a smaller proportion of their network members with whom they used drugs (p < .02). Using multiple logistic regression analyses and adjusting for baseline drug use, enrollment in drug treatment, and demographic and background variables, cessation of drug use was associated with a lower proportion of personal network members in one's drug network (odds ratio [OR] = 25.4, p < .05). The data from this study suggest that network members have potential for social influence on the cessation of drug use.

Adult↗
PubMed1976

The relationship between drug education programs in the Greater New Haven schools and changes in drug use and drug-related beliefs and perceptions.

This study presents a broad epidemiological approach to evaluation of drug education. Data on adolescent drug use and on drug-related beliefs and perceptions, collected yearly over a three-year period in 33 schools in the Greater New Haven area, were analyzed in relation to information on drug education programs in these schools. Changes in the general prevalence rates for the study period (1970-1973) and with age were the background against which the effects of the independent variable--presence or absence of specific drug education activities in the various schools--were explored. While the overall evidence suggested that drug education does not have a strong, across-the-board influence on either drug use rates or beliefs and perceptions, more modest and specific effects were noted which have implications for drug education.

Adolescent↗