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At least 19 recordsLinked to original sources
PubMed2001

Limitations in randomised controlled trials evaluating drug effects in mania.

Considering the increasing number of drugs evaluated for mania in randomised controlled trials (RCTs) and the potential discrepancies between recommendations based on RCTs and the antimanic treatment given in clinical practice, this paper addresses some issues related to RCTs on drug effects in mania. One major question raised in the paper is to what extent selection prior to the point of randomisation in RCTs in mania may limit the applicability of study results to patients seen in ordinary clinical practice. Although such limitations in generalisability can be difficult to investigate empirically, it is emphasised that they should be openly discussed in the reports of RCTs. Another major focus is the issue of evaluation and interpretation of outcome, including a discussion of various response criteria based on mania rating scale scores. It is pointed out that essential criteria of dimensionality have only been sufficiently evaluated for the Bech-Rafaelsen Mania Rating Scale, although the fulfilment of such criteria are prerequisites for adding up the item scores to a total score reflecting the severity of mania. It is suggested that response defined as a decline in mania score below a certain limit may have some advantages over the commonly used 50% reduction criterion. The issues arising from the unusual high drop-out rates of around 50% are also addressed. Despite the fact that we need rigorous placebo-controlled trials to establish antimanic efficacy of new compounds, we also need large scale pragmatic studies using broad inclusion criteria, comparing the various treatments, alone or in combination, to investigate how they work in clinical practice. These studies maybe randomised but open and use simple but relevant outcome measures.

Antimanic Agents↗
PubMed2005

Predicting inhibitory drug-drug interactions and evaluating drug interaction reports using inhibition constants.

OBJECTIVE: To review the use of inhibitory constants (Ki) determined from in vitro experiments in the prediction of the significance of inhibitory drug-drug interactions (DDIs). DATA SOURCES: Searches of MEDLINE (1966-August 2004) and manual review of journals, conference proceedings, reference textbooks, and Web sites were performed using the key search terms cytochrome P450, drug-drug interaction, inhibition constant, and Ki. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated, and information deemed relevant was included for this review. DATA SYNTHESIS: The cytochrome P450 isoenzymes factor prominently in the explanation of numerous DDIs. Although the regulation of these enzymes by one drug can affect the pharmacokinetics of other drugs, the consequences may not necessarily be significant either in terms of pharmacokinetic or clinical outcomes. Yet, many DDI monographs originate as unconfirmed case reports that implicate the influence of one drug on the CYP-mediated metabolism of another, and these often uncorroborated mechanisms can eventually become regarded as dogma. One consequence of this process is the over-prediction of potentially important DDIs. The pharmaceutical industry, Food and Drug Administration, and pharmaceutical scientists have developed a strategy for predicting the significance of inhibitory DDIs at the earliest possible stages of drug development based on a new chemical entity's Ki value, determined in vitro. CONCLUSIONS: We suggest that the use of Ki values of drugs purported to behave as CYP inhibitors be incorporated in the assessment of case reports that ascribe DDIs to inhibition of metabolism of one drug by another.

Area Under Curve↗
PubMed1999

[General principles of drug evaluation within the framework of drug policy].

This paper reviews the problems connected with drug evaluation in particular periods of its development. Requirements for drug registration, which represents the entrance of the drug on the market, are created by legislation. Drug application in the therapeutic process is determined by several factors and state regulations. The amount of evidence, reliability and validity of the facts should be the key factors of drug selection within the ambit of drug politics. Categorization of drugs means drug selection with regard to state reimbursement by means of health-insurance companies. Methods of drug categorization together with further regulations by means of positive letters, hospital blanks, should respect the criteria of professionality, transparency and sociopharmacology. Effective prognostication of drug use should ensure well-proportioned accessibility of effective safe drugs within the ambit of rational pharmacotherapy.

Drug Evaluation↗
PubMed1985

Evaluation of pharmacy and therapeutics committee drug evaluation reports.

Pharmacy and therapeutics (P & T) committee drug evaluation reports prepared by pharmacies and drug information centers (DICs) and product package inserts were compared with standard guidelines to evaluate their quality. Letters were sent to 143 hospital pharmacies asking them to submit a previously prepared drug evaluation report on temazepam, moxalactam disodium, or atenolol. The reports and package inserts for these three drugs were evaluated by the presence of 40 elements derived from the published ASHP guidelines for drug evaluation report preparation. Responses were obtained from 124 (87%) pharmacies; however, only 80 reports (60 DIC-prepared and 20 pharmacy-prepared) were received. The reports contained a mean of 28 of the 40 (70%) possible elements. The most frequently omitted elements were AHFS number, potential unlabeled uses, drug-drug interactions, drug-disease-laboratory test interactions, risk and benefit data, prevention and treatment of side effects, comparisons with established treatment, and disadvantages of the drug under consideration. Although the reports prepared by the DICs and pharmacies contained the same amount of information, the DIC-prepared reports included data more frequently on supply sources, therapeutic indications, approved labeling, comparison with established treatment, bioavailability and pharmacokinetics, and recommendations. Most of the reports contained more elements than the corresponding package inserts. The product package inserts did not contain the comparative elements required for P & T committee decisions. Both the pharmacy- and DIC-prepared reports failed to contain all 40 elements recommended in the standard guidelines, suggesting the need for more thorough reports.

Atenolol↗
PubMed1995

[Examination of some statistical evaluations of independence. Application to drug evaluation].

When two classes of events (E1, E2, ..., Em) on the one hand, (F1, F2, ..., Fn) on the other hand are such that the set of the m x n couples (Ei, Fj) represent all the possible issues of a common random experiment, it is often useful to know whether these two classes must be considered or not as independent of each other. In most cases, the answer to this important question is obtained through a chi 2-test and, less frequently, through various interpretations based upon the value rho of the linear correlation coefficient. A different method is also available to reach a conclusion, after estimating another coefficient mu characterizing the independence. The goal of the present lecture is to compare the possibilities, advantages and inconveniences of the three computational techniques leading to chi 2, rho and mu. Some examples of application to drugs evaluation are exposed.

Drug Evaluation↗
PubMed1992

Drug interaction microcomputer software evaluation: drug interaction facts on disk.

Drug Interaction Facts on Disk (DIF) was evaluated using general and specific criteria. The installation process, ease of learning and use, the user documentation, and the technical support were rated excellent. The scope of coverage, the quality of the clinical documentation, and overall clinical performance were also excellent. The frequency of updates is good. The program's clinical performance was compared to RxTriage and Drug Therapy Screening System using five recently reported drug interactions. The ability to screen for selected drug-food/nutrient interactions was also evaluated. Drug Interaction Facts is rated to be one of the better bargains in drug interaction software programs.

Drug Information Services↗
PubMed1982

Evaluating drug use behavior.

Evaluations of drug use behavior can be described as an emerging activity. There are a variety of stakeholders, a number of different activities, and a multitude of purposes for which evaluations have utility. A tentative codification of drugs use evaluations is offered that takes into account stakeholders, activities, and purposes. Summaries of completed and on-going studies are provided to illustrate the value of undertaking drug use evaluations.

Delivery of Health Care↗
PubMed1989

Drug interaction microcomputer software evaluation: Drug Master 89.

Drug Master 89 was evaluated using general and specific criteria. The installation process, ease of learning, and ease of use were rated excellent. The technical support, scope of coverage, and overall clinical performance were rated good. The quality of the clinical documentation and frequency of updates were fair, while the quality of the user documentation was poor. The program is valuable to the clinical dietician because of the comprehensiveness of its dietary and food interactions data base. For the practicing pharmacist, it performs reasonably well but other available programs are better values.

Dietetics↗
PubMed1990

Drug interaction microcomputer software evaluation: Drug Therapy Screening System (DTSS).

Drug Therapy Screening System (DTSS) was evaluated using general and specific criteria. The installation process, ease of learning and use, the user documentation, and the technical support were rated excellent. The scope of coverage, the quality of the clinical documentation, and overall clinical performance were also excellent. The frequency of updates is good. The program is one of the best microcomputer drug interaction software packages evaluated by the authors thus far, because of its comprehensiveness, simplicity in use, and quality of its drug interaction information. The relatively high annual cost may limit its attractiveness.

Drug Information Services↗
PubMed2000

Clinical drug evaluation: the regulatory perspectives.

INTRODUCTION: This paper presents the regulatory perspectives of the clinical drug evaluation process and the role of the newly established Centre for Drug Evaluation in Singapore in this process. It describes the major drug evaluation systems in the developed countries and their similarities and differences. METHODS: The issues related to the benefits and risks assessments of new drugs are discussed, with examples, against the backdrop of the various drug evaluation systems and medical practices. RESULTS: The implications of Singapore's Medicines (Clinical Trial) (Amendment) Regulations 1998 and the Singapore Good Clinical Practice Guidelines published by the Ministry of Health in 1998 were discussed. The future development of international harmonisation in the context of the International Conference on Harmonisation was explored. CONCLUSIONS: Building the capability for the evaluation of new drugs is essential as part of the regulatory infrastructure for a knowledge-based economy in Singapore. To conduct better clinical trials, investigators should develop a good understanding of the clinical drug evaluation process and an appreciation of the regulatory angle.

Clinical Trials as Topic↗