Articles Related to TEE

Aim: to demonstrate the PK/PD equivalence of an ovine enoxaparin to the reference product, the originator porcine enoxaparin, Lovenox® from Sanofi, and to assess its safety and tolerability in healthy volunteers with s.c. administration. Methods: a randomized, open-label, 2-way cross-over, single-dose study with 7 days wash-out period was conducted in healthy volunteers of both sexes. A single s.c. injection of 6,000 IU ovine enoxaparin from Metiska Farma (the test drug, T) or Lovenox® from Sanofi (the reference drug, R) was given randomly to each subject in fasting condition. The PD endpoints measured were anti-FXa and anti-FIIa activities in plasma, whereas the PD parameters determined for these endpoints were AUEC0-t (area under the effect curve from time 0 to the last measured activity (t)) and Amax (maximum activity). Bioequivalence (BE) is based on anti-FXa activity, the 90% CIs for GMR T/R (geometric means ratio of Test/ Reference) of AUEC0-t and Amax must fall within the BE limits of 80.00 – 125.00%. The anti-FIIa data are in vivo supportive evidence only. Results: a total of 23 healthy volunteers completed this study. The 90% CIs for GMR T/R of AUEC0-t and Amax for anti-FXa were 107.55 – 116.33% and 110.17 – 117.68%, respectively, while those for anti-FIIa were 100.93 – 122.56% and 105.19 – 124.44%, respectively. All parameters fell within the BE criteria of 80.00 – 125.00%. One AE (adverse event) occurred in one volunteer after s.c. injection of ovine enoxaparin, i.e. bruising which disappeared after a few days. Conclusions: the ovine enoxaparin from Metiska Farma was bioequivalent to the reference porcine enoxaparin (Lovenox®) from Sanofi. Both enoxaparin products were shown to have high safety and tolerability after a single dose in healthy volunteers. This is the first study showing BE of a nonporcine enoxaparin to the reference porcine enoxaparin in Indonesia, a Moslem country

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Purpose: The present bioequivalence study aimed at demonstrating the bioequivalence of a recently developed novel riluzole orodispersible film vs. a reference tablet. Methods: Healthy male and female volunteers received single oral doses of 50 mg of riluzole, as test and reference formulation, under fasting conditions, in each of 4 subsequent periods separated by wash-out intervals of at least 7 days, according to a 2-treatment, 4-period, replicate randomised cross-over design. Findings: Riluzole plasma concentrations were almost superimposable. Riluzole attained a similar peak concentration (315.62±124.95 ng/mL with the film and 278.81±123.32 ng/mL with the tablet) at a median tmax of 0.75 h after both treatments. Then, riluzole plasma concentrations showed a superimposable decline from the peak up to 36 h post-dose, with mean half-lives of 10.22±1.66 and 10.22±1.48 h with the film and the tablet. Mean AUC0-t was 1263.40±571.58 h*ng/mL with the film and 1135.98±514.98 h*ng/mL with the tablet. The 90% confidence intervals of Cmax, AUC0-t and AUC0-¥ of riluzole fell within the predefined range 80.00-125.00%. The treatments did not differ significantly either in tmax or t1/2. On average, the test orodispersible film dissolved on the tongue in a median time of about 2.5 min with a range of 0.7-5.7 min. Orodispersible film palatability was good or acceptable for most subjects.

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Tooth Size Discrepancy (TSD) forms part of the initial diagnosis and is considered when formulating a treatment plan for the individual patient. The present research aimed at determining the extent and prevalence in a representative orthodontic population in Libya, to determine the prevalence of tooth size discrepancies (TSDs) in orthodontic population among different malocclusion groups.

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To evaluate the prevalence of dental anomalies in the individuals with cleft lip and palate as well as to assess the incidence of differences among unilateral cleft lip and palate and bilateral cleft lip and palate subjects in terms of dental anomalies and sexual dimorphism.

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Donepezil is a potent, selective, noncompetitive and reversible inhibitor of acetylcholinesterase, commonly used for the treatment of Alzheimer’s disease. The form of orally disintegrating tablets (ODTs) is a good alternative dosage form for patients who have a difficulty in swallowing conventional tablets or capsules.

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Pantoprazole is a H+,K+-ATPase enzyme inhibitor for the treatment of acid-related gastrointestinal diseases. The Government Pharmaceutical Organization (GPO), Thailand had developed Pantoprazole GPO® (pantoprazole 40 mg delayed-release tablets) as a generic substitute for the corresponding innovator product, CONTROLOC® 40 mg.

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Fixed-dose combination tablet formulation of efavirenz/emtricitabine/tenofovir disoproxil fumarate 600/200/300 mg is an antiretroviral therapy comprising one non-nucleoside reverse-transcriptase inhibitor and two nucleoside reverse-transcriptase inhibitors to control human immunodeficiency virus infection.

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Tepilamide fumarate (PPC-06) is a new, patented prodrug of monomethyl fumarate (MMF), belonging to the fumaric acid esters (FAEs) class of drugs. The efficacy and safety of a 400 mg PPC-06 dose administered twice daily, achieved thus far through concomitant intake of two tablets of 200 mg, was demonstrated previously in two Phase 2 clinical trials on patients with moderate to severe chronic plaque-type psoriasis.

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Clopidogrel is used for acute coronary syndrome and prevention of atherothrombotic events. To improve clinical outcomes, patient adherence to treatment is necessary. However, continuous use of branded product may cause economic burden to patients and healthcare system. The Government Pharmaceutical Organization (GPO), Thailand had developed a generic product of clopidogrel to reduce cost of treatment and improve accessibility to medicines for Thai people.

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A comparative randomized, single dose, two-way crossover, open label study was carried out to assess bioequivalence and tolerability of test (ZOLAN GPO®) and reference (Zyprexa Zydis®) products of olanzapine 5 mg orally disintegrating tablets for interchange ability in the same quality and safety.

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Ectopic pregnancy is therefore implanted out of the normal implantation site of the uterine cavity. It is a surgical emergency that can compromise the vital prognosis and fertility of patients when the diagnosis is made at the stage of rupturing. Its incidence has doubled or even tripled in the world in the last two decades. Although it still remains the leading cause of maternal mortality in the first trimester by tubal rupturing accounting for 13% of maternal deaths this increase is closely linked to several factors such as sexually transmitted infections, history of salpingitis, tubal surgery, abortions, inert or progesterone associated IUD use and smoking. Tubal location is by far the most common (96 to 99% of cases). The clinical signs are therefore relatively late and the rupture of the tube is preceded by a fissure syndrome. We report a rare case of unruptured ampullary pregnancy that has evolved to 18 weeks.

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Dry socket is the most frequent post extraction complaint of patients, and it develops within 2 to 4 days after the extraction of tooth. This study is conducted to describe the predisposing or contributing factors associated directly or indirectly with the development of dry socket after the extraction of tooth at Oral and Maxillofacial Surgery Department of Peshawar Dental Collage and Hospital (PDC) Peshawar KPK.

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Tertiary education has always been regarded as highly stressful environment to students. Medical and health science training further add to the already stressful environment. Awareness of the existence of stress in medical students by physicians will help in diminishing student’s experience of stress. Therefore, identifying additional stressors in the clinical context is very crucial for providing measures to minimize students’ stress to a tolerable level and helping them to cope better. And the aim of this study is to assess perceived stress and factors associated with it among Bahir Dar University medical students, North West Ethiopia, 2016.

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Purpose: This study aimed to evaluate egg white-milk mixture as a novel storage medium for avulsed teeth compared to Hank’s Balanced Salt Solution (HBSS) media.Materials and media: Ninety incisors teeth of 23 New Zealand rabbits were atraumatically extracted and divided into 6 equal groups. Group 1, 2 & 3 were immediately stored in HBSS media for 1, 4 & 6h respectively, while group 4, 5 & 6 were stored in egg white-milk for 1, 4 & 6h respectively. The teeth were prepared for histological investigation and digital counting of periodontal ligament (PDL) cells using trypan blue exclusion technique.

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Infective Endocarditis (IE) is associated with significant morbidity and mortality, with in-hospital mortality having been reported as ranging from 19-26%. Commonly documented complications of IE include valvular and chordae destruction and resultant regurgitations, embolic events, peri-valvular abscesses, fistulae, and congestive heart failure.

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