LIVIVO - Search results -

Search results

Result 1 - 10 of total 36

Search options

Article ; Online: EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age.

Thor, Shannon / Vetter, Thorsten / Marcal, Anabela / Kweder, Sandra

Therapeutic innovation & regulatory science

2023 Volume 57, Issue 4, Page(s) 656–661

Abstract: As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared ... ...

Abstract	As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provides a mechanism for experts to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products (drugs, biologicals, vaccines, and advanced therapies).
MeSH term(s)	United States ; United States Food and Drug Administration ; Biological Products ; Government Agencies ; Medicine ; Drug Industry
Chemical Substances	Biological Products
Language	English
Publishing date	2023-03-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-023-00501-9
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

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.

Details ▾
- Full text online
- Order with fees

Article ; Online: Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations.

Hanaizi, Zahra / Kweder, Sandra / Thor, Shannon / Ribeiro, Sonia / Marcal, Anabela

Therapeutic innovation & regulatory science

2022 Volume 57, Issue 2, Page(s) 321–328

Abstract: The United States Food and Drug Administration and the European Medicines Agency (EMA) each have programs to expedite development of products identified as having potential to address unmet medical needs: the Breakthrough therapy (BT) and Regenerative ... ...

Abstract	The United States Food and Drug Administration and the European Medicines Agency (EMA) each have programs to expedite development of products identified as having potential to address unmet medical needs: the Breakthrough therapy (BT) and Regenerative Medicines Advanced Therapies designation programs in the US and the Priority Medicines (PRIME) scheme at EMA. We reviewed commonalities and differences in requests submitted and products designated through these programs, with the intent to explore ways to better support global development. During the period from PRIME's launch in April 2016 to 31 December 2020, 151 requests were made to both BT and PRIME programs and the agencies reached concordant outcomes to grant or deny requests for almost two thirds of the cases (93/151, 62%), suggesting similar perspectives across international regulators on the potential of the products under study. Forty-two (42/151, 28%) products were granted both BT and PRIME, thus found by both Agencies to have the potential to address an unmet need for a serious condition, and thereby products for which efficient development would be highly desirable. Working toward better engagement on global development strategies is in the best interests of patients and public health. With this in mind, Agencies and sponsors should take advantage of existing collaborative opportunities, such as parallel scientific advice, and work to identify fresh approaches to support global development of products for unmet medical needs.
MeSH term(s)	United States ; Humans ; Drug Approval ; Pharmaceutical Preparations ; United States Food and Drug Administration ; Regenerative Medicine
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2022-10-28
Publishing country	Switzerland
Document type	Review ; Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-022-00475-0
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

Order via subito

Details ▾
- Full text online
- Order with fees

Article: Meckel's diverticulitis in a COVID-19 adult.

Marçal, André / Marques, Rita / Oliveira, António / Pinto-de-Sousa, João

Journal of surgical case reports

2021 Volume 2021, Issue 3, Page(s) rjab059

Abstract: Meckel's diverticulitis is an unusual cause of acute abdomen condition in adults requiring prompt surgical treatment. We report a case of a 53-year-old male with coronavirus disease 19 (COVID-19), admitted to the emergency department with an acute ... ...

Abstract	Meckel's diverticulitis is an unusual cause of acute abdomen condition in adults requiring prompt surgical treatment. We report a case of a 53-year-old male with coronavirus disease 19 (COVID-19), admitted to the emergency department with an acute abdominal pain. A computed tomography scan with intravenous contrast performed on the patient confirmed an inflamed short segment of the small bowel and the presence of a localized free peritoneal fluid. The definitive diagnosis was made intraoperatively, by means of an emergent ileal resection with primary anastomosis, which confirmed Meckel's diverticulitis. Postoperative evolution was ordinary. The association of COVID-19 with the acute abdomen is found to be weak, therefore surgical consultation is advised to minimize delayed treatment.
Language	English
Publishing date	2021-03-29
Publishing country	England
Document type	Case Reports
ISSN	2042-8812
ISSN	2042-8812
DOI	10.1093/jscr/rjab059
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article: Prospective international validation of the predisposition, infection, response and organ dysfunction (PIRO) clinical staging system among intensive care and general ward patients.

Cardoso, T / Rodrigues, P P / Nunes, C / Almeida, M / Cancela, J / Rosa, F / Rocha-Pereira, N / Ferreira, I / Seabra-Pereira, F / Vaz, P / Carneiro, L / Andrade, C / Davis, J / Marçal, A / Friedman, N D

Annals of intensive care

2021 Volume 11, Issue 1, Page(s) 180

Abstract: Background: Stratifying patients with sepsis was the basis of the predisposition, infection, response and organ dysfunction (PIRO) concept, an attempt to resolve the heterogeneity in treatment response. The purpose of this study is to perform an ... ...

Abstract	Background: Stratifying patients with sepsis was the basis of the predisposition, infection, response and organ dysfunction (PIRO) concept, an attempt to resolve the heterogeneity in treatment response. The purpose of this study is to perform an independent validation of the PIRO staging system in an international cohort and explore its utility in the identification of patients in whom time to antibiotic treatment is particularly important. Methods: Prospective international cohort study, conducted over a 6-month period in five Portuguese hospitals and one Australian institution. All consecutive adult patients admitted to selected wards or the intensive care, with infections that met the CDC criteria for lower respiratory tract, urinary, intra-abdominal and bloodstream infections were included. Results: There were 1638 patients included in the study. Patients who died in hospital presented with a higher PIRO score (10 ± 3 vs 8 ± 4, p < 0.001). The observed mortality was 3%, 15%, 24% and 34% in stage I, II, III and IV, respectively, which was within the predicted intervals of the original model, except for stage IV patients that presented a lower mortality. The hospital survival rate was 84%. The application of the PIRO staging system to the validation cohort resulted in a positive predictive value of 97% for stage I, 91% for stage II, 85% for stage III and 66% for stage IV. The area under the receiver operating characteristics curve (AUROC) was 0.75 for the all cohort and 0.70 if only patients with bacteremia were considered. Patients in stage III and IV who did not have antibiotic therapy administered within the desired time frame had higher mortality rate than those who have timely administration of antibiotic. Conclusions: To our knowledge, this is the first external validation of this PIRO staging system and it performed well on different patient wards within the hospital and in different types of hospitals. Future studies could apply the PIRO system to decision-making about specific therapeutic interventions and enrollment in clinical trials based on disease stage.
Language	English
Publishing date	2021-12-23
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2617094-2
ISSN	2110-5820
ISSN	2110-5820
DOI	10.1186/s13613-021-00966-7
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article: Polypyrrole monolithic extraction phase: From conventional to miniaturized sample preparation techniques

Machado, Lucas S / Soares, Francielle Q / Martins, Rafael O / Bernardo, Ricardo A / Cardoso, Alessandra T / Ruggiero, Marçal A / Rabelo, Denilson / Souza, Paulo Sérgio / Chaves, Andréa R

Journal of chromatography. 2021 Aug. 16, v. 1651

2021

Abstract: Monolithic polymers are described as continuous and highly porous materials. They have been gaining popularity as an effective extracting phase for some sample preparation methods, due to their variety of functionalities, such as wide pH range tolerance, ...

Abstract	Monolithic polymers are described as continuous and highly porous materials. They have been gaining popularity as an effective extracting phase for some sample preparation methods, due to their variety of functionalities, such as wide pH range tolerance, good permeability, and its ability to allow changes into their surface. Polypyrrole represents an interesting alternative for the modification in extraction phases due to its well related ability to perform multiple interactions, such as acid-base, π - π, ion exchange, interactions with hydrophobic affinities or polar functional groups. Among the different sample preparation techniques, solid-phase extraction (SPE) is one of the most popular and used; a miniaturized version of SPE is the disposable pipette extraction (DPX). DPX is a recent miniaturized extraction technique that usually employing silica-based sorbents inside a pipette tip (5 or 1 mL). The present study proposes the development of a monolithic extraction phase composed by styrene divinylbenzene (1:1) modified with polypyrrole for SPE and DPX techniques. The efficiency of the material was evaluated in face of the extraction of different samples and analytes, triazine herbicides in water and dexamethasone in synthetic synovial liquid by conventional and miniaturized solid-phase extraction techniques. The extractions performed by SPE and DPX presented absolute recovery values ranging from 74.8 to 105.0%, inter-day precision ranging from 0.6 to 14.0%, and limit of quantification of 0.5 and 5.0 ng.mL⁻¹, respectively. The DPX miniaturized method exhibited results equivalent to the methods reported in the literature for extraction of dexamethasone in synovial fluid samples. Moreover, this technique proved to be quicker and cheaper than SPE, and produced fewer residual volumes, supporting the preference for green chemistry. Monolithic polymers modified with polypyrrole presented to be a feasible alternative extraction phase for miniaturized sample preparation techniques.
Keywords	chemical species ; chromatography ; dexamethasone ; green chemistry ; hydrophobicity ; ion exchange ; liquids ; pH ; permeability ; pyrroles ; solid phase extraction ; sorbents ; styrene ; synovial fluid
Language	English
Dates of publication	2021-0816
Publishing place	Elsevier B.V.
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	218139-3
ISSN	0021-9673 ; 0378-4355 ; 0376-737X
ISSN	0021-9673 ; 0378-4355 ; 0376-737X
DOI	10.1016/j.chroma.2021.462260
Database	NAL-Catalogue (AGRICOLA)

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 813: 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

Details ▾

Article: Right lumbar abscess containing a gallstone-an unexpected late complication of laparoscopic cholecystectomy.

Marçal, André / Pereira, Ricardo Vaz / Monteiro, Ana / Dias, José / Oliveira, António / Pinto-de-Sousa, João

Journal of surgical case reports

2020 Volume 2020, Issue 7, Page(s) rjaa248

Abstract: During laparoscopic cholecystectomy, gallbladder perforation may occur leading to gallstone spillage and despite being rare, early or late complications may therefore develop. We report a case of a 79-year-old female, with a past medical history of a ... ...

Abstract	During laparoscopic cholecystectomy, gallbladder perforation may occur leading to gallstone spillage and despite being rare, early or late complications may therefore develop. We report a case of a 79-year-old female, with a past medical history of a laparoscopic cholecystectomy 3 years earlier for symptomatic gallstones, admitted in the emergency department with a subcutaneous right lumbar abscess confirmed by computed tomography. Emergent abscess surgical drainage was performed and a gallstone was identified during saline lavage. Postoperative evolution was unremarkable and follow-up within a year was uneventful. Split gallstones due to gallbladder perforation during laparoscopic cholecystectomy should be retrieved in order to reduce future complications.
Language	English
Publishing date	2020-07-31
Publishing country	England
Document type	Case Reports
ISSN	2042-8812
ISSN	2042-8812
DOI	10.1093/jscr/rjaa248
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article: Pseudomyxoma peritonei

Gomes, Carina / Tenreiro, Nádia / Marçal, André / Moreira, Herculano / Pinto, Bruno / Avelar, Paulo

Journal of surgical case reports

2018 Volume 2018, Issue 7, Page(s) rjy148

Abstract: Abdominal wall hernia is a common and usually straightforward pathology presenting in surgery clinics. On occasion, the surgeon is faced with unexpected findings requiring difficult intraoperative decision. We present a case ... ...

Abstract	Abdominal wall hernia is a common and usually straightforward pathology presenting in surgery clinics. On occasion, the surgeon is faced with unexpected findings requiring difficult intraoperative decision. We present a case of
Language	English
Publishing date	2018-07-13
Publishing country	England
Document type	Case Reports
ISSN	2042-8812
ISSN	2042-8812
DOI	10.1093/jscr/rjy148
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Polypyrrole monolithic extraction phase: From conventional to miniaturized sample preparation techniques.

Machado, Lucas S / Soares, Francielle Q / Martins, Rafael O / Bernardo, Ricardo A / Cardoso, Alessandra T / Ruggiero, Marçal A / Rabelo, Denilson / Souza, Paulo Sérgio / Chaves, Andréa R

Journal of chromatography. A

2021 Volume 1651, Page(s) 462260

Abstract	Monolithic polymers are described as continuous and highly porous materials. They have been gaining popularity as an effective extracting phase for some sample preparation methods, due to their variety of functionalities, such as wide pH range tolerance, good permeability, and its ability to allow changes into their surface. Polypyrrole represents an interesting alternative for the modification in extraction phases due to its well related ability to perform multiple interactions, such as acid-base, π - π, ion exchange, interactions with hydrophobic affinities or polar functional groups. Among the different sample preparation techniques, solid-phase extraction (SPE) is one of the most popular and used; a miniaturized version of SPE is the disposable pipette extraction (DPX). DPX is a recent miniaturized extraction technique that usually employing silica-based sorbents inside a pipette tip (5 or 1 mL). The present study proposes the development of a monolithic extraction phase composed by styrene divinylbenzene (1:1) modified with polypyrrole for SPE and DPX techniques. The efficiency of the material was evaluated in face of the extraction of different samples and analytes, triazine herbicides in water and dexamethasone in synthetic synovial liquid by conventional and miniaturized solid-phase extraction techniques. The extractions performed by SPE and DPX presented absolute recovery values ranging from 74.8 to 105.0%, inter-day precision ranging from 0.6 to 14.0%, and limit of quantification of 0.5 and 5.0 ng.mL
MeSH term(s)	Adsorption ; Analytic Sample Preparation Methods ; Hydrophobic and Hydrophilic Interactions ; Miniaturization/methods ; Nitrogen/chemistry ; Polymerization ; Polymers/isolation & purification ; Pyrroles/isolation & purification ; Solid Phase Extraction ; Spectroscopy, Fourier Transform Infrared ; Temperature ; Water/chemistry ; Water Pollutants, Chemical/analysis
Chemical Substances	Polymers ; Pyrroles ; Water Pollutants, Chemical ; Water (059QF0KO0R) ; polypyrrole (30604-81-0) ; Nitrogen (N762921K75)
Language	English
Publishing date	2021-05-18
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1171488-8
ISSN	1873-3778 ; 0021-9673
ISSN (online)	1873-3778
ISSN	0021-9673
DOI	10.1016/j.chroma.2021.462260
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 813: 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

Details ▾

Article: Monitoring vegetation dynamics inferred by satellite data using the PhenoSat tool

Rodrigues, A. / Marcal, A. R. S. / Cunha, M.

IEEE Transactions on Geoscience and Remote Sensing

2013 Volume 51, Issue 4 Part 1, Page(s) 2096–2104

Abstract: normalized difference vegetation index (NDVI); phenology; PhenoSat; time series. [29986] ...

Institution	Centro de Investigacao em Ciencias Geo-Espaciais (CICGE), Faculdade de Ciencias, Universidade do Porto, 4169-007 Porto, Portugal
Abstract	normalized difference vegetation index (NDVI); phenology; PhenoSat; time series. [29986]
Language	English
Document type	Article
ISSN	0196-2892
DOI	10.1109/TGRS.2012.2223475
Database	Viticulture and Oenology Abstracts

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article: Image Processing of Artificial Targets for Automatic Evaluation of Spray Quality

Marçal, A.R.S / Cunha, M

Transactions of the ASABE. 2008 May-June, v. 51, no. 3

2008

Abstract: Abstract. A fully automatic methodology based on image processing is proposed to evaluate the quality of spray application sampled by water-sensitive papers (WSP). The methods proposed permit a computation of the fraction of spray coverage, an evaluation ...

Abstract	Abstract. A fully automatic methodology based on image processing is proposed to evaluate the quality of spray application sampled by water-sensitive papers (WSP). The methods proposed permit a computation of the fraction of spray coverage, an evaluation of the homogeneity of the spray spatial spread at various scales and directions, and extraction of stain and droplet size range and distribution. This allows the number of droplets per unit area and the standard droplet size spectra factors to be computed. The methods were tested with a number of test samples scanned at different resolutions, proving to be effective in situations where there is high spray coverage in the WSP, thus with considerable overlap between stains. The most suitable scanning resolution was found to be 600 dpi. The results obtained by the image processing methods were successfully compared with a manual (visual) counting of stains in a test sample.
Keywords	spray coverage ; spraying ; automation ; measurement ; methodology ; new methods ; droplet size ; image analysis
Language	English
Dates of publication	2008-05
Size	p. 811-821.
Document type	Article
Database	NAL-Catalogue (AGRICOLA)

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Details ▾

To top

Full text online

More links

Kategorien

Order via subito

Full text online

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Inter-library loan at ZB MED