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PubMed2006

Anticoagulants versus non-steroidal anti-inflammatories or placebo for treatment of venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE) is the term given to any thromboembolic event (blocking of a blood vessel by a blood clot) occurring in the venous system. The current treatment recommended for VTE is anticoagulation (reduction of the blood's ability to clot). The aim of this review is to summarize results from randomized controlled trials (RCTs) for the effectiveness of anticoagulants (heparins, including low molecular weight heparins and vitamin K antagonists) in the treatment of VTE, compared to non-steroidal anti-inflammatory drugs (NSAIDs) or placebo. OBJECTIVES: To examine the randomized controlled evidence for the effectiveness and safety of anticoagulant treatment compared to NSAIDs or placebo in patients with VTE on the incidence of fatal and non-fatal pulmonary emboli (PE) and the recurrence or extension of deep vein thrombosis (DVT). SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialized Trials Register (last searched 26 July 2005) and the Cochrane Central Register of Controlled Trials (CENTRAL) database (last searched Issue 3, 2005). In addition, DKC also searched reference lists and contacted pharmaceutical companies and experts in the field. SELECTION CRITERIA: All randomized trials of anticoagulants versus NSAIDs or placebo in the initial treatment of VTE (DVT or PE or both). DATA COLLECTION AND ANALYSIS: DKC and JM independently assessed trial quality and extracted data. JCP (biostatistician) analyzed the design elements and feasibility of a future randomized controlled trial to determine definitively efficacy and safety of anticoagulants in VTE treatment. MAIN RESULTS: Two RCTs were included. Data were not pooled because of heterogeneity between the studies. The two RCTs were too small to determine any difference in mortality, occurrence of pulmonary emboli, progression or return of DVT between patients treated with anticoagulation and those receiving no anticoagulation. AUTHORS' CONCLUSIONS: The limited evidence from RCTs of anticoagulants versus NSAIDs or placebo is inconclusive regarding the efficacy and safety of anticoagulants in VTE treatment. The use of anticoagulants is widely accepted in clinical practice, so a further RCT comparing anticoagulants to placebo could not ethically be carried out.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2003

Tramadol for pain relief in children undergoing tonsillectomy: a comparison with morphine.

BACKGROUND: Pain control for paediatric patients undergoing tonsillectomy remains problematic. Tramadol is reported to be an effective analgesic and to have a side-effect profile similar to morphine, but is currently not licensed for paediatric use in the UK. METHODS: We conducted a prospective, double-blind, randomized controlled trial in children who were scheduled for elective tonsillectomy or adenotonsillectomy at the Royal Aberdeen Children Hospital. Following local ethics committee approval and after obtaining a drug exemption certificate from the Medicines Licensing Agency for an unlicensed drug, we recruited 20 patients each into morphine (0.1 mg.kg(-1)), tramadol (1 mg.kg(-1)) and tramadol (2 mg.kg(-1)) groups. These drugs were given as a single injection following induction of anaesthesia. In addition, all patients received diclofenac (1 mg.kg(-1)) rectally. The postoperative pain scores, analgesic requirements, sedation scores, signs of respiratory depression and nausea and vomiting, as well as antiemetic requirements, were noted at 4-h intervals until discharge. RESULTS: There were no statistically significant differences in age, weight, type of operation or induction of anaesthesia, 4-h sedation and pain scores and further analgesic requirements. There were no episodes of respiratory depression. Morphine was associated with a significantly higher incidence of vomiting following discharge to the wards (75% versus 40%, P=0.03) compared with both tramadol groups. CONCLUSIONS: Tramadol has similar analgesic properties, when compared with morphine. The various pharmaceutical presentations and the availability as a noncontrolled substance may make it a useful addition to paediatric anaesthesia if it becomes licensed for paediatric anaesthesia in the UK.

Analgesics, Opioid↗
PubMed1992

In vivo NMR in pharmaceutical research.

In vivo NMR techniques are currently well established in pharmaceutical research and will likely become increasingly important in the future, as they procure noninvasively morphological, physiological, and biochemical information. The status of magnetic resonance imaging (MRI) and spectroscopy (MRS) in drug development is discussed on the basis of the characterization and evaluation of a rat model of ischemic stroke and the development and profiling of drugs for cerebral ischemia in this model. It can be concluded that MRI is well suited for drug screening (quantitative determination of lesion size), while dynamic MRI and MRS techniques provide relevant information on the mechanism of drug actions. The possibility to follow changes, pathological and therapeutic, in the same individual is important from two points of view. First, variations due to interindividual differences may be eliminated, increasing the statistical power of the results. Second, dose and/or time dependence of a drug can be explored in the same individual. As a result, the number of animals required for a study will be reduced, which from both ethical and economic aspects is highly desirable.

Animals↗
PubMed2002

[Research support and the pharmaceutical industry in Germany].

Improved life expectancy in the industrial world is a consequence of modern drug development and clinical research. Drug development requires long term investments. The costs for drug development increased considerably, because of higher safety and effectiveness standards. New drugs and the improvement of treatment strategies increased the success-rate and, at the same time, reduced the costs. In oncology drug development Germany ranks only second in global competition. Accelerations in the administrative processes of the universities for clinical research are urgently needed to better compete internationally. Furthermore the legal requirements installed in recent years hampered industrial and clinical research. Politics must see to it that Germany does not fall behind other industrial countries even further in the field of drug research and development.

Conflict of Interest↗
PubMed2006

Progress and problems for randomized clinical trials: from streptomycin to the era of megatrials.

Randomized clinical trials (RCTs) are the definitive contributors to evidence-based medicine. RCTs assessing serious outcomes in cardiovascular disease have grown, with 'megatrials' becoming more common with the realization that wrong conclusions resulted from random error in inadequately sized trials. Simple design and a heterogeneous patient population were early features, but multinational trials have increased in scientific, logistical, bureaucratic, regulatory, and legal complexity. These studies now exceed the financial means of academia or medical charities. Governments have left the bill with the pharmaceutical industry, encouraging a symbiosis with academics, who contribute medical and scientific expertise, and access to patients. Industry provides pharmacological, pharmaceutical, technical and regulatory know-how, good clinical practice expertise, and legal assistance during the trial. Study supervision is then in the hands of an independent steering committee and associated subcommittees, until appropriate dissemination of results. Prospectively defined interaction with the sponsor facilitates unbiased design and conduct, but arrangements need careful implementation to avoid conflicts of interest. The patient is protected by a strong data safety monitoring board that is wholly independent. Megatrials are under threat from over-regulation, increasing costs, and difficulties in execution. These issues merit urgent public and political education and debate.

Computer Security↗
PubMedDate not supplied

[Gene therapy: reality and expectations].

Chemical and pharmaceutical research have provided physicians with an array of drugs that have beneficial effects on a variety of diseases. Such drugs, however, mostly help in controlling the manifestations of the pathological condition but do not permanently modify the underlying cause. Hence the necessity of new forms of therapy that change drastically the current approach to medical treatment. Gene therapy, with its potential to correct the malfunctioning genes at the origin of variety of diseases, seems to fulfill the requirements of this therapeutic "revolution". The feasibility of such an approach is underscored by the improved knowledge of the molecular mechanism and/or gene defects at the origin of acquired diseases widely spread in the population, and of more rare congenital conditions. The technical advances in molecular biology and genetic engineering achieved in the last ten years, offer the tools necessary to implement such therapeutic interventions. Here we present the approaches currently employed for gene therapy in the context of recent clinical trials. The scientific, ethical and economical implications deriving from a prospective routine use of gene therapy in the clinical setting are discussed.

Female↗
PubMed2003

Drug excretion into breast milk--overview.

Breastfeeding is the optimal form of infant feeding for the first months of an infant's life, and the majority of healthy women initiate breastfeeding after the birth of their infant. However, women on medication may default to formula feeding or not taking their drug therapy for fear of exposing their infant to the medication through the breast milk. Although the majority of medications are considered to be compatible with breastfeeding, cases of significant infant toxicity exist, suggesting a case by case risk assessment to be made before the mother initiates breastfeeding or drug therapy. Unfortunately, current clinical risk assessment is often compromised by the paucity of data, as studies in breastfeeding women and their infants are ethically difficult to conduct. Circumventing the ethical constraints, approaches have been proposed to estimate drug excretion into milk from physicochemical characteristics of the drug, which diffuses through the mammary gland epithelia. However, as our understanding on drug transfer mechanisms increases, it has become abundantly clear that carrier-mediated processes are involved with excretion of a number of drugs into milk. This article provides an overview of the benefits of breastfeeding, the effect of medication use during breastfeeding on maternal decisions and infant health, and factors determining infant exposure to medication through the breast milk.

Breast Feeding↗
PubMed2004

Neurotoxicity of active compounds--establishment of hESC-lines and proteomics technologies for human embryo- and neurotoxicity screening and biomarker identification.

Pharmaceutical and chemical industries are facing new challenges for hazard and risk assessment from regulatory agencies. Especially for potential embryotoxicity of active compounds, conclusions from animal testing remain problematic due to numerous species-specific effects. Developmental toxicity screening preferentially should be performed with human material. Appropriate models are scarce or missing, and the development of a human in vitro model for the molecular characterisation of embryotoxic effects appears to be highly desirable. The outstanding advantages of a human embryonic stem cell (hESC) based in vitro screening model for embryonic neurotoxicity become clear from corresponding results from a murine ESC-screening system. This in vitro test system is based on neuronal differentiated murine embryonic stem cells and quantitative differential proteomic display techniques to identify biomarkers for neurotoxicity. Results are superior to those of conventional array technologies (nucleic acids), because the proteomic analysis covers posttranslational modifications. Under the new strict guidelines for stem cell importation of the German Ministry of Health and a Central Ethics Commission for Stem Cell Research, it is now possible for the first time to exploit the outstanding features of human embryonic stem cells to establish an innovative screening method for embryo- and neurotoxicity and to identify toxicity biomarkers without using animal-based in vitro or in vivo systems.

Animal Testing Alternatives↗
PubMed2006

Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system.

The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents2, which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA). During this stage the interested company submits to the regulatory agency, results from clinical studies that demonstrate the efficacy and safety of the new device or pharmaceutical product. Frequently, in addition to clinical studies, approval records for clinical use from the regulatory agencies of other countries, mainly the United States of America and the European Community are also submitted. The successful completion of this stage means that the medication or device may be prescribed or used by the physicians in Brazil. The second stage in the incorporation of new healthcare technology involves the reimbursement or financing of the treatment that was approved in the previous stage based on its efficacy and safety. This stage can be more complex than the first one since the new technology, whether a substitution for established treatment methods or the introduction of a new treatment concept, are usually more expensive. The incorporation of new technology requires a cost-effectiveness analysis so that fund administrators can make decisions based on the universal scenario of limited resources to finance healthcare with treatments that are more and more burdensome. The difficulties of funding management are aggravated by medical and social ethical implications that arise when a treatment is approved based on its efficacy and safety but is not made available to patients who could benefit greatly from it. In Brazil, assessment methods for the incorporation of new technology based on reimbursement or financing have not been fully developed for either the private healthcare plans or the Brazilian Public Healthcare System (SUS). The implementation of new technology in both healthcare systems is a slow process and frequently the implementation is a result of the requirements of patients or the organizations that represent them and at times is the result of legal proceedings or political pressure imposed by physicians and their respective scientific societies. Our objective is to review the evolution of percutaneous coronary intervention (PCI) in Brazil and its current status in view of the advent of drug-eluting stents, the growing participation of drug-eluting stents in myocardial revascularization to treat patients with coronary heart disease, as well as, to compare the regulatory standards from Brazil and other countries regarding the incorporation and recommendations for the use of this new technology.

Angioplasty, Balloon, Coronary↗
PubMed2006

The minipig in toxicology.

The use of pigs (Sus scrofa) in biomedical research is well established in particular in surgical and physiological research. For years both pigs and minipigs have been used in pharmacology and toxicology to answer specific questions when the more conventional species have been found unsuitable. The development of minipigs has resulted in strains of more manageable size than the domestic pig. Because of their well-accepted physiological and other similarities to humans, minipigs are becoming increasingly attractive toxicological and pharmacological models. There are several strains of minipigs (Göttingen, Yucatan, Sinclair, Hanford and other). This presentation is based on experience primarily with the Göttingen minipigs. In toxicology in Europe minipigs have become very popular for pharmaceutical studies in place of dogs and primates. Minipigs have been shown to be sensitive to a wide variety of drugs and chemicals. It has become obvious that minipigs can be used for all routes of administration, and in many cases are preferable to dogs or primates for metabolic or pharmacological reasons. There are advantages over the traditional non-rodent species in relation to specific responses to particular drug classes. Their use in general toxicology testing employing the continuous intravenous infusion, dermal or inhalation route has been described in detail in the literature. Background data on toxicological endpoints (ophthalmology, clinical pathology, ECG, organ weight, histopathology and reproduction parameters) have been well-established allowing studies to be interpreted. In the context of this conference, histopathology and toxicopathology data of spontaneous or drug-induced origin are available in the scientific literature. Now there is good supply of high-quality minipigs of known disease status. There are advantages over the traditional non-rodent species in relation to the ethical difficulties of use of animals in biomedical research. Consequently, there are scientific, economic and sociological reasons that make minipigs good toxicological and pharmacological models. The principal disadvantage is that toxicity testing in minipigs may require more test compound than the traditional species.

Animals↗
PubMed2002

Potential benefit of Bayesian forecasting for therapeutic drug monitoring in neonates.

Therapeutic drug monitoring in neonate has been hampered by invasiveness of blood samplings raising ethical problems. A methodologic approach has been developped in adults and in children that is still unsufficiently developped in neonates, the Bayesian forecasting of drug plasma concentration. This method is particularly attractive in neonates using a few blood samples from an individual patient and more informations from a prior patient sample representative of the population the individual patient belongs to. The present article aims at reviewing the different procedures and methods to minimize invasiveness during therapeutic drug monitoring in neonate and at reviewing the methods for improving the quality of different dose adjustments using a Bayesian approach.

Bayes Theorem↗
PubMed1977

The epidemiology of drug promotion.

A survey was conducted on the promotion of 28 prescription drugs in the form of 40 different products marketed in the United States and Latin America by 23 multinational pharmaceutical companies. Striking differences were found in the manner in which the identical drug, marketed by the identical company or its foreign affiliate, was described to physicians in the United States and to physicians in Latin America. In the United States, the listed indications were usually few in number, while the contraindications, warnings, and potential adverse reactions were given in extensive detail. In Latin America, the listed indications were far more numerous, while the hazards were usually minimized, glossed over, or totally ignored. The differences were not simply between the United States on the one hand and all the Latin American countries on the other. There were substantial differences within Latin America, with the same global company telling one story in Mexico, another in Central America, a third in Ecuador and Colombia, and yet another in Brazil. The companies have sought to defend these practices by contending that they are not breaking any Latin American laws. In some countries, however, such promotion is in clear violation of the law. The corporate ethics and social responsibilities concerned here call for examination and action.

Adrenal Cortex Hormones↗
PubMed2001

Human genome project: pharmacogenomics and drug development.

Now that all 30,000 or so genes that make up the human genome have been deciphered, pharmaceutical industries are emerging to capitalize the custom based drug treatment. Understanding human genetic variation promises to have a great impact on our ability to uncover the cause of individual variation in response to therapeutics. The study of association between genetics and drug response is called pharmacogenomics. The potential implication of genomics and pharmacogenomics in clinical research and clinical medicine is that disease could be treated according to the interindividual differences in drug disposition and effects, thereby enhancing the drug discovery and providing a stronger scientific basis of each patient's genetic constitution. Sequence information derived from the genomes of many individuals is leading to the rapid discovery of single nucleotide polymorphisms or SNPs. Detection of these human polymorphisms will fuel the discipline of pharmacogenomics by developing more personalized drug therapies. A greater understanding of the way in which individuals with a particular genotype respond to a drug allows manufacturers to identify population subgroups that will benefit most from a particular drug. The increasing emphasis on pharmacogenomics is likely to raise ethical and legal questions regarding, among other things, the design of research studies, the construction of clinical trials and the pricing of drugs.

Drug Design↗
PubMed2002

[Is preimplantation diagnosis legal?--on the need for harmonizing legislation].

Whether PGD is already legally permitted in Germany today is a moot point. A guidelines draft of the Germany's Federal General Medical Council, the Bundesärztekammer, on pre-implantation genetic diagnostics that--like the earlier findings of the ethics commission of the German federal state of the Rhineland-Palatinate--assumed that the method is admissible, if certain clearly-defined indications are present and a rigorous testing procedure has been established, has given the discussion a new impetus. The discussion is in full swing, with calls by politicians for the legislator to pass a regulation mounting. Of late, though, constitutional objections have been raised against a positive-law regulation. Such a simple legal move to regulate PGD, it is claimed, would violate the constitutionally-guaranteed right to inviolable human dignity. Critics, however, point out that such an absolute inviolability does not exist. According to them, not only the verdicts by the German Federal Constitutional Court, the Bundesverfassungsgericht, on the reform of section 218 of the German Federal Penal Code (StGB)--the paragraph that specifies the conditions under which an abortion is not punished--that relativize (in terms of the indication model) one claim to existence with respect to another, but also the approval in terms of pharmaceutical and medicine-products law of nidation-blocking agents, serve to show this. If the condition of being a human being were made to coincide with the completion of the genetic code upon the completion of the process of fertilisation, then one tended to forget, the critics noted, that this attendant dignity was not properly "infused with life" unless nidation had been successful. Without nidation everything were fragmentary, the total protection of human dignity according to Article 1 Section 1 of the Federal Republic's Basic Law, Germany's constitution, notwithstanding. During every in vitro fertilisation embryo transfer is conditional upon a variety of factors the presence of which is not noted until after fertilisation has taken place. On the part of the embryos, too, certain conditions have to be met whose presence at the moment of fertilisation is not assured. Thus an embryo with, for instance, defects that can be visually detected will not be transferred. With regard to these facts too the opponents of pre-implantation genetic diagnostics must be challenged to answer the question of why an embryo with visually-detectable defects should undoubtedly be allowed to be discarded, but the act of searching for "internal" defects be banned. Thus the fact remains that the mere acceptance of the loss of created embryos does not make artificial insemination a punishable offense, as long as the motive for the act is to bring about pregnancy. To achieve legal security for the couples and the physicians involved the law on the protection of embryos should be changed. The new regulations should determine under which conditions PGD is permissible. As is already the case for other norms that apply to reproductive medicine, but also for the practice of abortion, these regulations should contain an analogous right of refusal for the professionals involved. The laws relating to the healing professions, to the professional chambers, as well as the regulations of the various German federal states (which together constitute the Federal Republic of Germany) that apply to the professions should be amended accordingly.

Abortion, Induced↗
PubMed2005

The bioequivalence of highly variable drugs and drug products.

'Highly variable drugs' have been defined as those drugs for which the within-subject variability (WSV) equals or exceeds 30% of the maximum concentration (Cmax) and/or the area under the concentration versus time curve (AUC). Despite the fact that highly variable drugs are generally safe with flat dose response curves, the bioequivalence of their formulations is a problem because the high variability means that large numbers of subjects are required to give adequate statistical power. Highly variable drug products are poor quality formulations where high within-formulation variability (e.g. tablet to tablet variability) poses a problem rather than high innate WSV of the drug itself. A further problem caused by high variability is that a subset of the population may respond differently to the two formulations producing a significant subject x formulation interaction. Practical examples are shown using replicate designs. The methods proposed to deal with the problems posed by highly variable drugs include: (i) Drug regulatory jurisdictions states that the 90% confidence interval (90% CI) around the test to reference geometric mean ratio (GMR) is required to fit with bioequivalence acceptance limits of 0.8 - 1.25 for both Cmax and AUC. The WSV for single point estimation of Cmax is often greater than that for AUC. One strategy therefore is not to require a 90% CI for Cmax of drugs that do not exhibit a toxicity associated with Cmax and merely require the GMR to fall within the acceptance limits. (ii) To arbitrarily broaden the bioequivalence acceptance limits. For example, to permit a sponsor to justify the use of wider limits e.g the 90% CI around the GMR of Cmax values might be required to fit within acceptance limits of 0.75 - 1.33 or even 0.70 - 1.42. (iii) A more systematic approach would be to broaden the acceptance limits by scaling to either the residual variance from a 2-period design or to the WSV of the reference product in a replicate design. Subsequent evaluations of scaling procedures have demonstrated that smaller numbers of subjects are required for bioequivalence studies on formulations of highly variable drugs. A disadvantage of scaling is that the method is less sensitive to differences between the means compared with unscaled treatment, such that the GMR may prove to be unacceptably low or high. This possibility has let to a suggestion that the GMR must fall within acceptance limits of 0.8 - 1.25 in scaled treatments. (iv) A similar method is to scale the metric rather than the acceptance limits. This method was proposed by the United States' Food and Drug Administration in the context of Individual bioequivalence, but may also be applied (v) to average bioequivalence. (vi) To carry out bioequivalence studies at steady state whenever a multiple dose regimen is ethically acceptable for healthy volunteers. This solution is based on the observation that high variability in a single dose study tends to be dampened at steady state, thus increasing statistical power. Drug regulators have not favored this approach on the grounds that bioequivalence testing should be based on the most discriminating test possible. (vii) Finally the use of metabolite data has been proposed since in many (but by no means all) cases, metabolite is less highly variable than that of the parent drug. This subject remains controversial except when the administered substance is a prodrug which converted by metabolism into the active drug.

Area Under Curve↗
PubMed2006

Genetic research and testing in critical care: surrogates' perspective.

OBJECTIVE: Genetic testing is increasingly a component of clinical research in critical illness and has potential for integration into routine care. This study explored the perspectives of surrogate decision-makers (SDMs) for acutely ill patients with respect to social, legal, and ethical aspects of genetic testing. SETTING: Medical and surgical intensive care units in an urban tertiary care hospital. INTERVENTION: Questionnaires administered to SDMs for critically ill patients over a 12-month period. MEASUREMENTS AND MAIN RESULTS: A majority of eligible SDMs participated (117/146; 80.8%). SDMs were more likely to permit genetic testing for purposes of diagnosing a treatable life-threatening disease (114/117; 97.4%) or chronic disease (111/117; 94.9%) than for an untreatable life-threatening illness (95/117; 81.2%) (p < .001). SDMs were receptive to testing to explain familial traits (112/117; 95.7%) or ethnic traits (105/117; 89.7%) (p = .131). SDMs were concerned about potential for economic discrimination, with a majority expressing reluctance to permit testing if employers (93/117; 79.5%), health insurers (90/117; 76.9%), or life insurers (92/117; 78.6%) could access results. There was a greater willingness to allow participation in studies in which data were collected anonymously (90/117; 76.9%) vs. nonanonymously (75/117; 64.1%) (p = .04). Finally, SDMs placed greater trust in universities and nonprofit organizations (107/117; 91.4%) than either the federal government (75/117; 64.1%) or pharmaceutical companies (46/117; 39.3%) to perform genetic research (p < .01). CONCLUSIONS: SDMs expressed concerns regarding economic discrimination, confidentiality of data, and trust in entities conducting clinical investigation that may represent barriers both to performing studies in which genetic information is collected and to implementation of gene-based technologies in the critical care environment.

Biomedical Research↗
PubMed1997

Clinical pharmacokinetic registration file for NDA and ANDA procedures.

Pharmacokinetics is a relatively young branch of the life sciences, which has developed rapidly in the last 15-20 years, thanks to a series of analytical achievements that have allowed drug concentrations to be measured in biological matrices with highly selective and sensitive methods. Most old drugs and all new drugs have been investigated in depth to determine their absorption, distribution, metabolism and elimination. This has produced a huge body of data which have characterized drugs through so-called fingerprint parameters. Today, pharmacokinetics plays a vital role throughout drug development from initial non-clinical studies to clinical trials. In new drug development, simultaneous efforts in pharmacodynamic and pharmacokinetic studies have produced a high degree of synergy, the most useful expression of which is the identification of a therapeutic window, where this can be achieved. Dose linearity/proportionality, gender effect, metabolism and possible polymorphism, studies on neonates/children and on elderly and diseased patients and the population approach, relative and absolute bioavailability, possible interactions and the possible presence of a deep compartment in the distribution are other important applications of pharmacokinetics. Major new developments in pharmaceutical technology which have produced controlled-release delivery systems and the market introduction of generics would never have occurred but for the active contribution of pharmacokinetics. This review is devoted to the investigations needed to prepare appropriate pharmacokinetic registration files for new drug applications (NDAs) and abbreviated or abridged new drug applications (ANDAs) required for generic drugs. Scientific literature, operating guidelines and personal experience are the basis of this review, which describes a number of relevant examples in several specific areas.

Adult↗
PubMed1992

[Pharmaceutical companies as sponsors of clinical trials--advantages and limitations].

The therapeutic progress achieved in the second half of this century was made possible only due to the interest taken by the pharmaceutical industry in the research field. It can be considered as the primum movens of the therapeutic revolution which has strongly benefited the humanity in these last decades. The clinical trials of new drugs constitute an integral part of the pharmaceutical and medical research. However its complexity and the costs involved make its execution impossible without the help or sponsorship of the pharmaceutical firms. Even in the more advanced countries it would be unthinkable that clinical trials could be carried out without the assistance of the pharmaceutical industry. The sponsorship by the pharmaceutical firms turns the relationship doctor-firm into a symbiotic association as both the parties reap benefits thereof: the physician because he is able to satisfy his inquisitiveness and his interest for the clinical research and the pharmaceutical firm because through these trials it will collect the information it requires. Besides having to bear the expenses inherent to the research, the sponsoring firms equally contribute for other pursuits usually of academical character and of interest to the investigator. Therefore it is not rare that these firms assume the costs of presence of these investigators in scientific meetings or to contribute for the arrangements of such meetings or even subsidise the acquisition of the equipment for the hospital services, etc.--measures which in countries with poor investments in research sector, such as Portugal, may constitute the only possibility to be carried out.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗