LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 41

Search options

  1. Article ; Online: Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products.

    Raney, Sam G / Ghosh, Priyanka / Ramezanli, Tannaz / Lehman, Paul A / Franz, Thomas J

    Dermatologic clinics

    2022  Volume 40, Issue 3, Page(s) 319–332

    Abstract: The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Several test methods have been discussed ... ...

    Abstract The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Several test methods have been discussed and developed to evaluate topical bioavailability (BA) and BE. Pharmacokinetics-based approaches characterize the rate and extent to which an active ingredient becomes available at or near its site of action in the skin. Such methodologies are considered to be among the most accurate, sensitive, and reproducible approaches for determining the BA or BE of a product.
    MeSH term(s) Administration, Cutaneous ; Biological Availability ; Humans ; Skin/metabolism ; Therapeutic Equivalency
    Language English
    Publishing date 2022-06-02
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 82798-8
    ISSN 1558-0520 ; 0733-8635
    ISSN (online) 1558-0520
    ISSN 0733-8635
    DOI 10.1016/j.det.2022.02.007
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Se 851: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  2. Article ; Online: Twelve-Month Outcomes of Patients With Myocardial Injury not Due to Type-1 Myocardial Infarction.

    Rocheleau, Simon / Eng-Frost, Joanne / Lambrakis, Kristina / Khan, Ehsan / Chiang, Brian / Wattchow, Naomi / Steele, Simon / Lorensini, Scott / Lehman, Sam J / Papendick, Cynthia / Chew, Derek P

    Heart, lung & circulation

    2023  Volume 32, Issue 8, Page(s) 978–985

    Abstract: Background: Diagnosis of acute myocardial infarction (AMI) requires a combination of elevated cardiac troponins, and clinical or echocardiographic evidence of coronary ischaemia. Identification of patients with a high likelihood of coronary plaque ... ...

    Abstract Background: Diagnosis of acute myocardial infarction (AMI) requires a combination of elevated cardiac troponins, and clinical or echocardiographic evidence of coronary ischaemia. Identification of patients with a high likelihood of coronary plaque rupture (Type 1 myocardial infarction [MI]) is crucial as it is these patients for whom coronary intervention has been well-established to provide benefit and reduce subsequent coronary ischemic events. However, high-sensitivity cardiac troponin (hs-cTn) assays have increasingly identified patients with hs-cTn elevations not due to Type 1 MI where recommendations for ongoing care are currently limited. Understanding the profile and clinical outcomes for these patients may inform the development of an emerging evidence-base.
    Methods: Using two previously published studies (hs-cTnT study n=1,937, RAPID-TnT study n=3,270) and the Fourth Universal Definition of MI, index presentations of patients to South Australian emergency departments with suspected AMI, defined by high sensitivity cardiac troponin T (hs-cTnT) greater than the upper reference limit (14 ng/L) and without obvious corresponding ischaemia on electrocardiogram (ECG), were classified as either Type 1 MI (T1MI), Type 2 MI (T2MI), acute myocardial injury (AI), or chronic myocardial injury (CI). Patients with non-elevated hs-cTnT (defined as <14 ng/L) were excluded. Outcomes assessed included death, MI, unstable angina, and non-coronary cardiovascular events within 12 months.
    Results: In total, 1,192 patients comprising 164 (13.8%) T1MI, 173 (14.5%) T2MI/AI, and 855 (71.7%) CI were included. The rate of death or recurrent acute coronary syndrome was greatest in patients with T1MI, but also occurred with moderate frequency in Type 2 MI/AI and CI (T1MI: 32/164 [19.5%]; T2MI/AI: 24/173 [13.1%]; CI:116/885 [13.6%]; p=0.008). Of all the deaths observed, 74% occurred among those with an initial index diagnostic classification of CI. After adjusting for age, gender and baseline comorbidities, the relative hazard ratios for non-coronary cardiovascular readmissions were similar across all groups: Type 2 MI/AI: 1.30 (95% confidence interval 0.99-1.72, p=0.062); CI: 1.10 (95% confidence interval 0.61-2.00, p=0.75).
    Conclusions: Non-T1MI accounted for the majority of patients presenting with elevated hs-cTnT without ischaemia on ECG. Patients with T1MI had the highest rates of death or recurrent AMI; however patients with T2MI/AI and CI experienced a substantial rate of non-coronary cardiovascular re-hospitalisations.
    MeSH term(s) Humans ; Australia ; Myocardial Infarction/diagnosis ; Myocardial Infarction/epidemiology ; Acute Coronary Syndrome ; Troponin T ; Comorbidity ; Heart Injuries ; Biomarkers
    Chemical Substances Troponin T ; Biomarkers
    Language English
    Publishing date 2023-05-22
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2020980-0
    ISSN 1444-2892 ; 1443-9506
    ISSN (online) 1444-2892
    ISSN 1443-9506
    DOI 10.1016/j.hlc.2023.04.299
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 4988: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: The Tritiated Water Skin Barrier Integrity Test: Considerations for Acceptance Criteria with and Without

    Lehman, Paul A / Beatch, Kacie / Raney, Sam G / Franz, Thomas J

    Pharmaceutical research

    2017  Volume 34, Issue 1, Page(s) 217–228

    Abstract: Purpose: A study was designed to assess barrier integrity simultaneously using separate compounds (probes) for polar and non-polar pathways through the skin, : Methods: A 5-min dose of water containing : Results: The correlation between : ... ...

    Abstract Purpose: A study was designed to assess barrier integrity simultaneously using separate compounds (probes) for polar and non-polar pathways through the skin,
    Methods: A 5-min dose of water containing
    Results: The correlation between
    Conclusions: The results of the
    Language English
    Publishing date 2017-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 843063-9
    ISSN 1573-904X ; 0724-8741 ; 0739-0742
    ISSN (online) 1573-904X
    ISSN 0724-8741 ; 0739-0742
    DOI 10.1007/s11095-016-2057-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1937: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  4. Article ; Online: Impacts of high sensitivity troponin T reporting on care and outcomes in clinical practice: Interactions between low troponin concentrations and participant sex within two randomized clinical trials.

    Lambrakis, Kristina / Khan, Ehsan / van den Merkhof, Anke / Papendick, Cynthia / Chuang, Anthony / Zhai, Yuze / Eng-Frost, Joanne / Rocheleau, Simon / Lehman, Sam J / Blyth, Andrew / Briffa, Tom / Quinn, Stephen / French, John K / Cullen, Louise / Chew, Derek P

    International journal of cardiology

    2023  Volume 393, Page(s) 131396

    Abstract: Background: The impacts of high sensitivity cardiac troponin (hs-cTn) reporting on downstream interventions amongst suspected acute coronary syndrome (ACS) in the emergency department (ED), especially amongst those with newly identified hs-cTn ... ...

    Abstract Background: The impacts of high sensitivity cardiac troponin (hs-cTn) reporting on downstream interventions amongst suspected acute coronary syndrome (ACS) in the emergency department (ED), especially amongst those with newly identified hs-cTn elevations and in consideration of well-established sex-related disparities, has not been critically evaluated to date. This investigation explores the impact of hs-cTnT reporting on care and outcomes, particularly by participant sex.
    Methods: Two similarly ED-based randomized controlled trials conducted between July 2011 to March 2013 (n = 1988) and August 2015 to April 2019 (n = 3378) were comparatively evaluated. Clinical outcomes were adjudicated to the Fourth Universal Definition of MI. Changes in practice were assessed at 30 days, and death or MI were explored to 12 months.
    Results: The HS-Troponin study demonstrated no difference in death or MI with unmasking amongst those with hs-cTnT <30 ng/L, whereas the RAPID TnT study demonstrated a significantly higher rate. In RAPID TnT, there was significant increase in death or MI associated with unmasking for females with hs-cTnT <30 ng/L (masked: 11[1.5%], unmasked: 25[3.4%],HR: 2.27,95%C.I.:1.87-2.77,P < 0.001). Less cardiac stress testing with unmasking amongst those <30 ng/L was observed in males in both studies, which was significant in RAPID TnT (masked: 92[12.0%], unmasked: 55[7.0%], P = 0.008). In RAPID TnT, significantly higher rates of angiography in males were observed with unmasking, with no such changes amongst females <30 ng/L (masked: 28[3.7%], unmasked: 51[6.5%],P = 0.01).
    Conclusion: Compared with males, there were no evident impacts on downstream practices for females with unmasking in RAPID TnT, likely representing missed opportunities to reduce late death or MI.
    MeSH term(s) Male ; Female ; Humans ; Troponin T ; Randomized Controlled Trials as Topic ; Acute Coronary Syndrome/diagnosis ; Acute Coronary Syndrome/therapy ; Emergency Service, Hospital ; Troponin I ; Biomarkers
    Chemical Substances Troponin T ; Troponin I ; Biomarkers
    Language English
    Publishing date 2023-09-26
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 779519-1
    ISSN 1874-1754 ; 0167-5273
    ISSN (online) 1874-1754
    ISSN 0167-5273
    DOI 10.1016/j.ijcard.2023.131396
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1673: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article ; Online: Glutamate

    Reslane, Itidal / Handke, Luke D / Watson, Gabrielle F / Shinde, Dhananjay / Ahn, Jong-Sam / Endres, Jennifer L / Razvi, Fareha / Gilbert, Emily A / Bayles, Kenneth W / Thomas, Vinai C / Lehman, McKenzie K / Fey, Paul D

    Journal of bacteriology

    2024  Volume 206, Issue 2, Page(s) e0033723

    Abstract: Genome sequencing has demonstrated ... ...

    Abstract Genome sequencing has demonstrated that
    MeSH term(s) Staphylococcus aureus/metabolism ; Glutamic Acid/metabolism ; Arginine/metabolism ; Bacterial Proteins/metabolism ; Transcription Factors/metabolism ; Amino Acids/metabolism ; Proline/genetics ; Proline/metabolism ; Gene Expression Regulation, Bacterial
    Chemical Substances Glutamic Acid (3KX376GY7L) ; Arginine (94ZLA3W45F) ; Bacterial Proteins ; Transcription Factors ; Amino Acids ; Proline (9DLQ4CIU6V)
    Language English
    Publishing date 2024-02-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 2968-3
    ISSN 1098-5530 ; 0021-9193
    ISSN (online) 1098-5530
    ISSN 0021-9193
    DOI 10.1128/jb.00337-23
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ud II Zs.50: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  6. Article: Impact of increased augmentation index and valvuloarterial impedance on symptom recovery after aortic valve replacement for severe aortic stenosis.

    Jones, Dylan R / Chew, Derek P / Horsfall, Matthew J / Sinhal, Ajay R / Joseph, Majo X / Baker, Robert A / Bennetts, Jayme S / Selvanayagam, Joseph B / Russell, Andrew E / De Pasquale, Carmine G / Lehman, Sam J

    International journal of cardiology. Heart & vasculature

    2021  Volume 32, Page(s) 100705

    Abstract: Background: Aortic stenosis (AS) is a common valvular disorder with a large symptomatic burden resulting from increased myocardial workload due to valvular obstruction. The contribution of increased afterload from arterial stiffness on symptoms is ... ...

    Abstract Background: Aortic stenosis (AS) is a common valvular disorder with a large symptomatic burden resulting from increased myocardial workload due to valvular obstruction. The contribution of increased afterload from arterial stiffness on symptoms is uncertain. The purpose of this analysis was to determine the symptomatic impact of arterial stiffness as determined by Applanation Tonometry.
    Methods: Eighty-eight patients with severe AS undergoing intervention with transcatheter aortic valve replacement (TAVR) (n = 65) or surgical aortic valve replacement (SAVR) (n = 23) were prospectively enrolled. Symptoms were recorded using the NYHA Class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and a 6 min walk test (6MWT) at baseline, and 1- and 6-months post intervention. Pulse Wave Analysis (PWA) using Applanation Tonometry was performed at all reviews, including the augmentation index (AIx).
    Results: Patients undergoing TAVR were older, with worse renal function and lower aortic valve areas, but were otherwise similar. There was no significant difference between the augmentation index of our AS population compared with an age matched reference population (p = 0.89).Symptoms significantly improved after intervention according to NYHA Class, KCCQ and 6MWT. Additionally, with adjustment, the initial augmentation index correlated with the final KCCQ (Coeff. = -0.383, p = 0.02) and NYHA Class (Coeff. = 0.012, p = 0.03) and a baseline AIx value in the top quartile resulted in a significantly worse final KCCQ (95.1 v 85.2, p = 0.048) relative to the bottom 3 quartiles.
    Conclusions: According to our analysis, an elevated baseline AIx is associated with a poorer symptomatic recovery after aortic valve intervention and so is worthy of consideration when assessing potential symptomatic benefit.
    Language English
    Publishing date 2021-01-06
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 2818464-6
    ISSN 2352-9067
    ISSN 2352-9067
    DOI 10.1016/j.ijcha.2020.100705
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  7. Article ; Online: Impact of Surgical and Transcatheter Aortic Valve Replacement on Frailty Score.

    Jones, Dylan R / Chew, Derek P / Horsfall, Matthew J / Sinhal, Ajay R / Joseph, Majo X / Baker, Robert A / Bennetts, Jayme S / Selvanayagam, Joseph B / Harris, Josephine H / De Pasquale, Carmine G / Lehman, Sam J

    Heart, lung & circulation

    2021  Volume 31, Issue 4, Page(s) 566–574

    Abstract: Objective: Frailty is common in the aortic stenosis (AS) population and impacts outcomes after both transcatheter and surgical aortic valve replacement (TAVR and sAVR, respectively). Frailty can significantly impact the decision regarding the ... ...

    Abstract Objective: Frailty is common in the aortic stenosis (AS) population and impacts outcomes after both transcatheter and surgical aortic valve replacement (TAVR and sAVR, respectively). Frailty can significantly impact the decision regarding the suitability of a patient for aortic valve intervention, with frail patients often excluded. Since many frailty tools use indicators which may be influenced by AS itself, some of which are subjectively symptom driven, we sought to determine the impact of intervention on frailty scores.
    Methods: A prospective, observational cohort study included patients being assessed for aortic valve (AV) intervention with either TAVR or sAVR due to severe aortic stenosis. Patients were assessed for symptoms at baseline, and 1- and 6-months post intervention subjectively, using the New York Heart Association (NYHA) class and the Kansas City Cardiomyopathy Questionnaire (KCCQ), and objectively, using a 6-minute walk test (6MWT). These were compared with frailty at baseline and final review using the Fried Frailty Scale (FFS).
    Results and conclusions: Sixty-six (66) patients completed pre- and post-intervention reviews. The mean FFS score was significantly lower, indicating less frailty, at 6 months relative to pre procedure (1.18 vs 1.73, p=0.002). This correlated with the change in symptoms (p<0.001). Between intervention groups, the final mean FFS of both groups decreased significantly, with TAVR to 1.33 (p=0.030) and sAVR to 0.8 (p=0.015). There was no difference in the degree of improvement between interventions (p=0.517). Aortic valve intervention improves frailty scores in both TAVR and sAVR treated patients.
    MeSH term(s) Aortic Valve/surgery ; Aortic Valve Stenosis/diagnosis ; Aortic Valve Stenosis/surgery ; Frailty/diagnosis ; Heart Valve Prosthesis Implantation/methods ; Humans ; Prospective Studies ; Risk Factors ; Transcatheter Aortic Valve Replacement/methods ; Treatment Outcome
    Language English
    Publishing date 2021-10-14
    Publishing country Australia
    Document type Journal Article ; Observational Study
    ZDB-ID 2020980-0
    ISSN 1444-2892 ; 1443-9506
    ISSN (online) 1444-2892
    ISSN 1443-9506
    DOI 10.1016/j.hlc.2021.09.014
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 4988: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  8. Article: Bivalirudin in percutaneous coronary intervention.

    Lehman, Sam J / Chew, Derek P

    Vascular health and risk management

    2007  Volume 2, Issue 4, Page(s) 357–363

    Abstract: Bivalirudin is a member of the direct thrombin inhibitor group of anticoagulants. It has been evaluated as an alternative to unfractionated and low-molecular-weight heparins in the settings of percutaneous coronary intervention (PCI) and acute coronary ... ...

    Abstract Bivalirudin is a member of the direct thrombin inhibitor group of anticoagulants. It has been evaluated as an alternative to unfractionated and low-molecular-weight heparins in the settings of percutaneous coronary intervention (PCI) and acute coronary syndrome (ACS). Results of clinical trials to date suggest bivalirudin is a viable alternative to the use of a heparin combined with a glycoprotein (GP) IIb/IIIa inhibitor in these settings. Thrombin has a central role in coagulation and platelet activation in ACS and during PCI. Its direct inhibition is an attractive target for therapy in these settings. Bivalirudin is a 20 amino acid polypeptide hirudin analog. It displays bivalent and reversible binding to the thrombin molecule, inhibiting its action. Direct inhibition of thrombin with bivalirudin has theoretical pharmacokinetic and pharmacodynamic advantages over the indirect anticoagulants. A reduction in rates of bleeding without loss of anti-thrombotic efficacy has been a consistent finding across multiple clinical trials. There may be economic benefits to the use ofbivalirudin if it permits a lower rate of use of the GP IIb/IIIa inhibitors. This article reviews the pharmacology of bivalirudin and clinical trial evidence to date. There are now data from multiple clinical trials and meta-analyses in the setting of ACS and PCI. Early results from the acute catheterization and urgent intervention strategy (ACUITY) trial are discussed.
    MeSH term(s) Acute Disease ; Angioplasty, Balloon, Coronary/adverse effects ; Anticoagulants/adverse effects ; Anticoagulants/therapeutic use ; Hemorrhage/chemically induced ; Heparin/therapeutic use ; Hirudins/adverse effects ; Humans ; Myocardial Ischemia/drug therapy ; Myocardial Ischemia/metabolism ; Myocardial Ischemia/prevention & control ; Peptide Fragments/adverse effects ; Peptide Fragments/therapeutic use ; Platelet Aggregation Inhibitors/therapeutic use ; Recombinant Proteins/adverse effects ; Recombinant Proteins/therapeutic use ; Secondary Prevention ; Syndrome ; Thrombin/antagonists & inhibitors ; Thrombin/metabolism ; Thrombosis/etiology ; Thrombosis/metabolism ; Thrombosis/prevention & control
    Chemical Substances Anticoagulants ; Hirudins ; Peptide Fragments ; Platelet Aggregation Inhibitors ; Recombinant Proteins ; Heparin (9005-49-6) ; Thrombin (EC 3.4.21.5) ; bivalirudin (TN9BEX005G)
    Language English
    Publishing date 2007-02-22
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 2186568-1
    ISSN 1178-2048 ; 1176-6344
    ISSN (online) 1178-2048
    ISSN 1176-6344
    DOI 10.2147/vhrm.2006.2.4.357
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 6066: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  9. Article ; Online: Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products.

    Raney, Sam G / Franz, Thomas J / Lehman, Paul A / Lionberger, Robert / Chen, Mei-Ling

    Clinical pharmacokinetics

    2015  Volume 54, Issue 11, Page(s) 1095–1106

    Abstract: The pharmacokinetic approach has accelerated the development of high-quality generic medicines with extraordinary cost savings, transforming the pharmaceutical industry and healthcare system in the USA. While this is true for systemically absorbed drug ... ...

    Abstract The pharmacokinetic approach has accelerated the development of high-quality generic medicines with extraordinary cost savings, transforming the pharmaceutical industry and healthcare system in the USA. While this is true for systemically absorbed drug products, the availability of generic versions of topical dermatological products remains constrained due to the limited methods accepted for bioequivalence evaluation of these products. The current review explores the possibility of developing appropriate bioequivalence approaches based on pharmacokinetic principles for topical dermatological products. This review focuses on the strengths and limitations of the three most promising pharmacokinetics-based methods to evaluate the performance and bioequivalence of topical dermatological products, which include in vivo skin stripping, in vivo microdialysis, and in vitro permeation testing (IVPT) with excised human skin. It is hoped that recent advances in pharmaceutical and regulatory science will facilitate the development of robust bioequivalence approaches for these dosage forms, enable more efficient methodologies to compare the performance of new drug products in certain pre-approval or post-approval change situations, and promote the availability of high-quality generic versions of topical dermatological products.
    MeSH term(s) Administration, Topical ; Dermatologic Agents/administration & dosage ; Dermatologic Agents/pharmacokinetics ; Humans ; In Vitro Techniques ; Skin/drug effects ; Skin/metabolism ; Skin Absorption/drug effects ; Therapeutic Equivalency
    Chemical Substances Dermatologic Agents
    Language English
    Publishing date 2015-11
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 197627-8
    ISSN 1179-1926 ; 0312-5963
    ISSN (online) 1179-1926
    ISSN 0312-5963
    DOI 10.1007/s40262-015-0292-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1246: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  10. Article: Multidisciplinary transcatheter aortic valve replacement heart team programme improves mortality in aortic stenosis.

    Jones, Dylan R / Chew, Derek P / Horsfall, Matthew J / Chuang, Anthony Ming-Yu / Sinhal, Ajay R / Joseph, Majo X / Baker, Robert A / Bennetts, Jayme S / Selvanayagam, Joseph B / Lehman, Sam J

    Open heart

    2019  Volume 6, Issue 2, Page(s) e000983

    Abstract: Objectives: To analyse the effect of the implementation of a transcatheter aortic valve replacement (TAVR) and multidisciplinary heart team programme on mortality in severe aortic stenosis (AS).: Methods: A retrospective, observational cohort study ... ...

    Abstract Objectives: To analyse the effect of the implementation of a transcatheter aortic valve replacement (TAVR) and multidisciplinary heart team programme on mortality in severe aortic stenosis (AS).
    Methods: A retrospective, observational cohort study was performed using the echocardiography, cardiothoracic surgery and TAVR databases between 1 January 2006 and 31 December 2016. Outcomes were compared between the pre- and post-TAVR programme eras in a tertiary referral centre providing transcatheter and surgical interventions for AS.All-cause mortality within 5 years from diagnosis was determined for 3399 patients with echocardiographically defined severe AS.
    Results: Of 3399 patients, there were 210 deaths (6.2%) at 30 days and 1614 deaths (47.5%) at 5 years.Overall, patients diagnosed in the post-TAVR programme era were older, with a lower ejection fraction and more severe AS, but were less comorbid.Among 705 patients undergoing intervention, those in the post-TAVR programme era were older, with a lower ejection fraction and more severe AS but no significant differences in comorbidities.Using an inverse probability weighted cohort and a Cox proportional hazards model, a significant mortality benefit was noted between eras alone (HR=0.86, 95% CI 0.77 to 0.97, p=0.015). When matching for age, comorbidities and valve severity, this benefit was more evident (HR=0.82, 95% CI 0.73 to 0.92, p=0.001).After adjusting for the presence of aortic valve intervention, a significant benefit persisted (HR=0.84, 95% CI 0.75 to 0.95, p=0.005).
    Conclusion: The implementation of a TAVR programme is associated with a mortality benefit in the population with severe AS, independent of the expansion of access to intervention.
    Language English
    Publishing date 2019-07-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 2747269-3
    ISSN 2053-3624 ; 2044-6055
    ISSN 2053-3624 ; 2044-6055
    DOI 10.1136/openhrt-2018-000983
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

To top