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PubMed2006

Tumor models for efficacy determination.

The first in vivo tumor models were developed in the mid-1960s. These models were mouse leukemia models grown as ascites. The growth pattern was like that of bacteria in vivo and therefore it was possible to apply similar mathematics of growth and response to these tumors as had been worked out for bacteria. Since the development of the murine leukemia models, investigators have devoted a large effort to modeling solid tumors in mice. There are now a variety of models including syngeneic mouse tumors and human tumor xenografts grown as s.c. nodules, syngeneic mouse tumors and human tumor xenografts grown in orthotopic sites, models of disseminated disease, "labeled" tumor models that can be visualized using varied technologies, and transgenic tumor models. Each of these types of models has advantages and disadvantages to the "drug hunter" searching for improved treatments.

Animals↗
PubMedDate not supplied

An in vitro study to determine efficacy of different wax-dispersing agents.

An in vitro study was performed to compare the relative efficacy of a number of aqueous- and organic-based wax-dispersing preparations. Water, which was originally intended to be a control, surprisingly proved to be the most effective, whilst olive oil appeared to be almost totally ineffective as a wax dispersant. In view of the relatively high cost of commercially available preparations, these results have significant clinical potential.

Arachis↗
PubMed1984

Factors determining efficacy of NSAIDs.

This article reviews the efficacy of NSAIDs and their pharmacokinetic and pharmacodynamic properties. The assumption that classic pharmacokinetic dose/plasma concentration response relationships can be applied to NSAIDs has tenuous support in the biomedical literature. Comparative efficacy studies, using ASA and indomethacin as the standards for comparison, ignore the fact that the major outcome variables are subjective responses among patients, not among drugs. Comparing inhibition of platelet malonyldialdehyde, synovial drug concentrations, urinary prostaglandin metabolites, and plasma free and total concentration with the clinical outcome provides no guidelines to serve as predictors of response. The individual agents, indomethacin, salicylates, sulindac, piroxicam, and naproxen, illustrate the complexities of NSAID pharmacotherapy. Recent proliferation of newer NSAIDs will not add significantly to the efficacy of these agents in the treatment of pain and inflammatory disease states. However, knowledge of pharmacokinetic population parameters for the individual NSAIDs will increase the likelihood of therapeutic success and diminish the possibilities for adverse reactions.

Anti-Inflammatory Agents↗
PubMed1978

Recurrence as a mode of determining efficacy in treatment of carcinoma of the larynx.

A study population of 374 patients with cancer of the larynx was evaluated, treated, and followed at yearly intervals up to a maximum of 18 years post-diagnosis. Of these, 348 received definitive therapy to attempt to eradicate their disease and were followed for recurrence and presence of cancer at death. In Stages I, II, and III recurrence of disease appears to be a very good indicator of therapeutic efficacy. Stage I carcinomas of the larynx should be treated with radiation as the proportions of patients with recurrences were the same for both primary surgical or radiation therapy. In Stages II and III, primary surgical therapy significantly lowered the proportion recurring when compared with primary radiation therapy. In Stage IV carcinomas of the larynx, both survival and recurrence accurately reflect therapeutic efficacy since most patients suffer recurrence of their carcinoma and die of the disease.

Age Factors↗
PubMed1993

Radioimmunodetection of colorectal cancer metastases with 131I-labeled monoclonal antibody B72.3: a pilot study to determine efficacy of detection and pharmacokinetics.

We performed radioimmunoscintigraphy (RIS) and/or pharmacokinetic (PCK) studies in 12 patients with primary or metastatic colorectal carcinoma, utilizing an intravenous administration of 1-4 mCi (1 mg) of 131I-B72.3 monoclonal antibody. Metastatic lesions were correctly identified in 4/8 patients by RIS. Two patients with small lesions (> 2 cm diameter) had a false-negative RIS scan. Two patients had a true-negative RIS scan. Optimal images were obtained at 1 week postinjection. PCK studies showed that the plasma clearance of 131I-B72.3 was biexponential with an alpha-phase half-life ranging from 0.5 to 7.1 hr and a beta-phase half-life ranging from 47.5 to 85.3 hr. Systemic and renal clearance data indicated that 131I-B72.3 was cleared very slowly and almost entirely by deiodination. This pilot study was conducted to gain an understanding of the pharmacokinetics of this radiolabeled antibody. On the basis of these data, we are now studying second-generation antibodies as part of our long-range objectives to incorporate them in early detection and treatment protocols.

Adult↗
PubMed1992

Field trial to determine efficacy of an Escherichia coli J5 mastitis vaccine.

Efficacy of an Escherichia coli (O111:B4) J5 bacterin for preventing naturally occurring IMI and clinical mastitis was tested in a 2.5-yr field trial in a 225-cow commercial herd. Cows with odd-numbered identification were vaccinated, and cows with even-numbered identification served as unvaccinated controls for each lactation during the study. Immunizations were subcutaneous on the upper part of the rib cage just posterior to the scapula at drying off, 30 d after drying off, and at calving. Percentage of quarters infected at calving with Gram-negative bacteria did not differ between treatment groups. A total of 67% of Gram-negative bacterial IMI present at calving in control cows became clinical during the first 90 d of lactation compared with 20% in vaccinated cows. Rate of Gram-negative bacterial clinical mastitis was higher in control cows than in vaccinated cows during the first 90 d of lactation. Immunization with the E. coli J5 bacterin did not reduce level of Gram-negative bacterial IMI at calving but did reduce incidence of clinical mastitis.

Animals↗
PubMed2002

Non-linear fitting of mechanical data for efficacy determination of single versus double bundle Achilles tendon grafts for PCL reconstructions.

The Posterior Cruciate Ligament (PCL) consists of two primary bundles and is the primary restraint to posterior tibial translation. The emergence of the Posterior Tibial Inlay Technique (PTIT) has demonstrated a mechanical advantage over the commonly used Tibial Tunnel Method (TTM). This study was designed to investigate the effects on knee mechanics from both a Single-bundle (SB) and Double-bundle (DB) Achilles tendon PCL reconstruction using a PTIT. The investigators hypothesized that a DB graft demonstrates a mechanical advantage compared to the SB graft. A materials testing machine provided six sequential loading cycles of 100 N while total translation was measured. The testing was conducted at 90 degrees, 60 degrees, 30 degrees and 10 degrees of flexion in neutral tibial rotation. While the mechanical advantages of the DB graft were detected, specifically at small laxity values and in the physiological range of normal gait, the additional complexity of the technique may clinically outweigh the mechanical advantages.

Achilles Tendon↗
PubMed1990

Toward a unified theory of ganglioside-mediated functional restoration after brain injury: lesion size, not lesion site, is the primary factor determining efficacy.

Pharmacological intervention is receiving increasing attention as a strategy to promote recovery of function after central nervous system injury. In this review we describe numerous studies indicating that gangliosides have been particularly successful in promoting CNS repair across a wide spectrum of brain areas and behavioral paradigms. A detailed comparison of these studies reveals common features among those studies where ganglioside treatment was found to be beneficial and those where no effect was observed. Specifically, treatment efficacy was only seen in those paradigms where recovery occurs naturally after the injury and not in those where either the behavioral deficit was too small ("ceiling effect") or too extensive for spontaneous recovery to occur ("floor effect"). Thus, ganglioside treatment is only effective in cases of moderate (partial) injury and/or when behavioral recovery occurs naturally. The effect is independent of lesion site or lesion type. On the basis of these observations, we propose a model based on the relationships of neural aggregates (cell groups) which have either a primary or modulatory role in brain function. Our model may provide a heuristic basis for future research efforts aimed at elucidating the mechanism(s) whereby gangliosides enhance brain repair.

Animals↗
PubMed1987

Long-term therapy with biosynthetic human insulin: importance of short-acting/intermediate-acting insulin ratio on determining efficacy of treatment.

This report describes the efficacy of biosynthetic human insulin (BHI) in long-term (one year) therapy of type I diabetic patients previously treated with conventional insulins. The results were compared with those obtained in a group of diabetic patients kept on their usual treatment. In the latter, fasting plasma glucose, HbA1, insulin dose and relative proportions of insulin formulations remained constant throughout the study. In patients switched to BHI, hypoglycaemic episodes occurred during the first week of treatment and fasting plasma glucose was higher than basally at the first two visits (7th and 30th days). Both hypoglycaemia and high fasting plasma glucose were avoided by reducing the amount of short-acting insulin and increasing that of intermediate-acting insulin, so that the short-acting/intermediate-acting insulin ratio was significantly lower during BHI therapy, although the total daily insulin dose remained unchanged. HbA1 levels remained fairly constant throughout the study. It was concluded that in order to achieve full clinical efficacy of BHI, it is important to modify the proportions of short- and intermediate-acting insulin preparations accurately when switching patients from conventional insulin to biosynthetic human insulin.

Adult↗
PubMed1996

Determining efficacy of electroepilation treatments.

Evaluating the efficacy of electroepilation treatments must begin by establishing a baseline for each proposed treatment site. However, the need for identifying a baseline for epilation patients is often overlooked. The Electroepilation Charting System is a simple, systematic, standardized evaluation method which enables evaluation of treatment methods as well as new products as they are introduced into the marketplace.

Hair Removal↗
PubMed2005

Electrophoretic component of electric pulses determines the efficacy of in vivo DNA electrotransfer.

Efficient DNA electrotransfer can be achieved with combinations of short high-voltage (HV) and long low voltage (LV) pulses that cover two effects of the pulses, namely, target cell electropermeabilization and DNA electrophoresis within the tissue. Because HV and LV can be delivered with a lag up to 3000 sec between them, we considered that it was possible to analyze separately the respective importance of the two types of effects of the electric fields on DNA electrotransfer efficiency. The tibialis cranialis muscles of C57BL/6 mice were injected with plasmid DNA encoding luciferase or green fluorescent protein and then exposed to various combinations of HV and LV pulses. DNA electrotransfer efficacy was determined by measuring luciferase activity in the treated muscles. We found that for effective DNA electrotransfer into skeletal muscles the HV pulse is prerequisite; however, its number and duration do not significantly affect electrotransfer efficacy. DNA electrotransfer efficacy is dependent mainly on the parameters of the LV pulse(s). We report that different LV number, LV individual duration, and LV strength can be used, provided the total duration and field strength result in convenient electrophoretic transport of DNA toward and/or across a permeabilized membrane.

Animals↗
PubMed2003

Safety, efficacy and determinants of effectiveness of antimalarial drugs during pregnancy: implications for prevention programmes in Plasmodium falciparum-endemic sub-Saharan Africa.

Plasmodium falciparum malaria in pregnancy poses substantial risk to a pregnant woman and her neonate through anaemia and low birth weight (LBW), respectively, and is responsible for up to 35% of preventable LBW in malaria-endemic areas. Chemoprophylaxis or intermittent preventive treatment (IPT) with an effective antimalarial can ameliorate the adverse effects of malaria during pregnancy. Current guidelines from the WHO recommend that women in highly malarious areas receive IPT with an effective antimalarial. Two central considerations in evaluating drugs for use during pregnancy are safety for the mother and her foetus and effectiveness, which is determined by efficacy, cost, availability, deliverability and acceptability of the drug. These factors may be scored and potential drugs or drug combinations ranked in order of potential effectiveness for use in prevention programmes. The seven most promising regimens are all IPT, primarily because they are more easily delivered and less expensive than chemoprophylaxis. Currently, IPT with sulphadoxine-pyrimethamine (SP) is more likely to have the best overall effectiveness in preventing adverse outcomes associated with malaria in pregnancy. Its low cost, wide availability, easy deliverability and acceptability make it the clear choice in countries where efficacy of the drug remains good. For countries where resistance to SP is rising or already high, amodiaquine (alone or in combination with SP or artesunate) artesunate + SP, chlorproguanil-dapsone (with and without artesunate) and artemether-lumefantrine require urgent evaluation for use in pregnancy.

Africa South of the Sahara↗