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- Bad trials are a scandal that need to be stopped
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Authors:
Wiffen; P.
Pages: 179 - 179
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2022-003405
Issue No: Vol. 29, No. 4 (2022)
- Factors influencing the implementation of clinical pharmacy services on
paediatric patient care in hospital settings-
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Authors:
Sin, C. M.-H; Huynh, C, Dahmash, D, Maidment, I. D.
Pages: 180 - 186
Abstract: ObjectivesThis systematic review (SR) was undertaken to identify and summarise any factors which influence the implementation of paediatric clinical pharmacy service (CPS) from service users’ perspectives in hospital settings.MethodsLiterature search from EMBASE, MEDLINE, Web of Science (Core Collection), Cochrane Library, Scopus and CINAHL databases were performed in order to identify any relevant peer-reviewed quantitative and qualitative studies from inception until October 2019 by following the inclusion criteria. Boolean search operators were used which consisted of service, patient subgroup and attribute domains. Studies were screened independently and included studies were quality assessed using Mixed Methods Appraisal Tool. The study was reported against the ‘Enhancing Transparency in Reporting the Synthesis of Qualitative Research’ statement.Results4199 citations were screened by title and abstract and 6 of 32 full publications screened were included. There were two studies that were graded as ‘high’ in quality, with four graded as ‘moderate’. The analysis has led to the identification of seven factors categorised in five predetermined overarching themes. These were: other healthcare professionals’ attitudes and acceptance; availability of clinical pharmacist on ward or outpatient settings; using drug-related knowledge to perform clinical activities; resources for service provision and coverage; involvement in a multidisciplinary team; training in the highly specialised areas and development of communication skills.ConclusionEvidence for paediatric CPS was sparse in comparison to a similar SR conducted in the adult population. An extensive knowledge gap within this area of practice has therefore been identified. Nevertheless, majority of the factors identified were viewed as facilitators which enabled a successful implementation of CPS in paediatrics. Further research is needed to identify more factors and exploration of these would be necessary in order to provide a strong foundation for strategic planning for paediatric CPS implementation and development.
Keywords: Editor''s choice, EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002520
Issue No: Vol. 29, No. 4 (2022)
- Haemorrhagic complications in patients with renal insufficiency during
treatment or prophylaxis with dalteparin-
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Authors:
Diaz Gomez, E; Suarez Del Olmo, D, Corregidor Luna, L, Iglesias-Peinado, I, Garcia Diaz, B.
Pages: 187 - 191
Abstract: ObjectivesLow-molecular-weight heparins are widely used in clinical practice for the treatment or prophylaxis of venous thromboembolism (VTE). As these drugs are eliminated mainly by renal means, any renal function impairment may lead to higher plasma concentrations and increase the risk of bleeding. This study aims to evaluate whether in clinical practice there is an increase in the occurrence of bleeding in patients with renal insufficiency (RI) during treatment or prophylaxis with dalteparin, and to analyse the risk factors potentially influencing the appearance of such bleeding events.MethodsPatients were sampled from the Universitary Severo Ochoa Hospital, Leganés, Spain. This was a retrospective cohort study with a 1 year inclusion period, conducted at a Spanish university hospital with 400 beds, on patients undergoing treatment or prophylaxis for VTE with dalteparin for a minimum of 3 days. The main outcome measure was the number of patients who had bleeding events, independently of their severity, during dalteparin administration in patients with RI.Results367 patients were included in the study. Bleeding occurred in 17.9% of patients in the group with RI and in 7.3% of patients with normal renal function (NRF). Most haemorrhages in both cohorts were grade 2 on the WHO scale (64.7% in the RI group and 69.2% in the NRF group). Logistic regression analysis allowed the presence of RI (MDRD-4 (Modification of Diet in Renal Disease)
Keywords: EAHP Statement 5: Patient Safety and Quality Assurance
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002262
Issue No: Vol. 29, No. 4 (2022)
- Effects of pretreatment with terazosin and valsartan on intraoperative
haemodynamics in patients with phaeochromocytoma-
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Authors:
Ji, Q; Li, F, Zhang, X, Wang, Y, Liu, C, Chang, Y.
Pages: 192 - 197
Abstract: ObjectiveSurgery is the primary strategy for treating phaeochromocytoma (PCC), but it can lead to severe hypertension and heart failure. Although valsartan is effective in reducing high blood pressure, clinical data on the potential role of valsartan in PCC are currently limited. Therefore, the aim of this study was to investigate the effects of pretreatment with terazosin and valsartan on patients with PCC.MethodsIn this retrospective cohort study, 50 patients who underwent laparoscopic resection of PCC were enrolled. During preoperative preparation, the patients (n=25) in the control group were treated with terazosin, while those (n=25) in the combination treatment group were treated with terazosin and valsartan. The levels of catecholamine hormones before and after surgery were determined, and the intraoperative blood pressure and the incidence of complications were compared between the two groups.ResultsThe results showed no significant differences in baseline patient characteristics or surgical conditions between the two groups (p>0.05). However, on the third day after surgery, the levels of catecholamine hormones in the two groups were significantly lower than those before surgery (p
Keywords: EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002375
Issue No: Vol. 29, No. 4 (2022)
- Impact of CYP2C19 and CYP2C9 gene polymorphisms on sodium valproate plasma
concentration in patients with epilepsy-
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Authors:
Song, C; Li, X, Mao, P, Song, W, Liu, L, Zhang, Y.
Pages: 198 - 201
Abstract: BackgroundValproic acid (VPA) is a broad spectrum anticonvulsant drug, which could be partially metabolised by cytochrome P450 (CYP) 2C9 and 2C19 enzymes. This study was designed to investigate the relationship between CYP2C19 and CYP2C9 gene polymorphisms and the plasma concentrations of VPA in subjects with epilepsy.MethodsEighty-three subjects with epilepsy aged 18–92 years were enrolled in this study. All were treated with sustained-release VPA monotherapy. Based on the genotypes of CYP2C19 and the ability to metabolise substrates, the subjects were divided into poor metabolisers, intermediate metabolisers and extensive metabolisers. Sanger sequencing was used to detect the genotypic and allelic frequencies of CYP2C19 (*1, *2 and *3) and CYP2C9 (*13) of the patients. Automatic immunity analysis was used to find steady-state trough plasma concentrations of VPA. By adjusting the plasma concentrations of VPA with body weight and total daily dose of VPA, the concentration-to-dose ratio of VPA (CDRV) was obtained. Data were analysed using SPSS software.ResultsThe genetic frequencies of CYP2C19*2, CYP2C19*3 and CYP2C9*13 were 33.1%, 3.0% and 5.4%, respectively, among patients with epilepsy from Yunnan province, China who used VPA therapy. The CDRV was significantly lower in the CYP2C19 extensive metabolisers (3.33±1.78) than it was in the CYP2C19 intermediate metabolisers (4.45±1.42) and the CYP2C19 poor metabolizers (6.64±1.06). The CYP2C19*2 and CYP2C19*3 alleles were correlated with the plasma VPA concentration, while the CYP2C9*13 allele had no effect on the plasma VPA concentration (p=0.809).ConclusionsThe genetic polymorphisms of CYP2C19 significantly affect the VPA plasma concentration, and the dosage of VPA for intermediate and poor metabolisers could be lower than for extensive metabolisers. CYP2C9*13 carrier was not closely related to plasma concentrations of VPA in patients with epilepsy.
Keywords: EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002367
Issue No: Vol. 29, No. 4 (2022)
- Effects of antifungal drugs on the plasma concentrations and dosage of
tacrolimus in kidney transplant patients-
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Authors:
Cheng, S; Tang, M, Du, J, Yin, T.
Pages: 202 - 206
Abstract: ObjectivesTacrolimus is one of the three basic immunosuppressants used following kidney transplantation, and its plasma concentration is susceptible to antifungal drugs. Abnormal tacrolimus concentrations may lead to adverse outcomes for patients. Adjustment of the tacrolimus dose after administering antifungal drugs to patients with fungal infection after transplantations therefore has important clinical significance. Our objective is to measure the impact of antifungal drugs on the plasma concentration of tacrolimus in kidney transplant patients.MethodsA retrospective study was carried out in 109 kidney transplant recipients treated with a tacrolimus-based regimen and antifungal drugs simultaneously. Tacrolimus levels and dosage requirements were compared before and during antifungal therapy.ResultsThe plasma levels of tacrolimus were significantly increased after the combination with voriconazole and fluconazole (p
Keywords: EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002385
Issue No: Vol. 29, No. 4 (2022)
- Discontinuation due to neuropsychiatric adverse events with efavirenz- and
dolutegravir-based antiretroviral therapy: a comparative real-life study-
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Authors:
Fernandez-Bargiela, N; Rotea-Salvo, S, Margusino-Framinan, L, Balboa-Barreiro, V, Martin-Herranz, I, Castro-Iglesias, A, Mena-De-Cea, A, Lopez-Calvo, S, Vazquez-Rodriguez, P, Miguez-Rey, E, Cid-Silva, P.
Pages: 207 - 211
Abstract: ObjectivesDespite the high efficacy of antiretroviral treatment, no drug is free from adverse events (AEs). Efavirenz (EFV) and dolutegravir (DTG) are antiretroviral drugs for which neuropsychiatric adverse events (NPAEs) have been described. This study evaluated the safety and tolerability of DTG-based and EFV-based antiretroviral regimens in HIV-infected patients.MethodsA retrospective observational study was carried out in HIV-infected patients who started DTG- or EFV-based antiretroviral treatment from January 2008 to December 2018 at a reference hospital in north-western Spain. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed with SPSS software.ResultsA total of 282 DTG- and 148 EFV-based therapies were initiated. During follow-up, statistically significant differences have been found between the rate of patients who discontinued DTG and EFV due to AEs (12.1% vs 35.8%, p
Keywords: EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002374
Issue No: Vol. 29, No. 4 (2022)
- Assessment of the stability of citrate-buffered piperacillin/tazobactam
for continuous infusion when stored in two commercially available
elastomeric devices for outpatient parenteral antimicrobial chemotherapy:
a study compliant with the NHS Yellow Cover Document requirements-
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Authors:
Jamieson, C; Ozolina, L, Seaton, R. A, Gilchrist, M, Hills, T, Drummond, F, Wilkinson, A. S, on behalf of the BSAC Drug Stability Testing Working Group, Gilchrist, Hills, Santillo, Andrew Seaton, Ozolina, Wilkinson
Pages: 212 - 216
Abstract: ObjectivesTo investigate the effect of pH control through the use of a citrate-buffered saline diluent pH 7 on the degradation rate of piperacillin/tazobactam solutions for infusion and to determine if an extended shelf-life of up to 13 days fridge 2°C–8°C plus 24 hours ‘in-use’ at 32°C in two elastomeric devices: FOLFusor LV10 (Baxter Healthcare, Thetford, UK) and Easypump II (B. Braun Medical Ltd, Sheffield, UK) can be achieved.MethodsTesting was as per the latest National Health Service (NHS) Pharmaceutical Quality Assurance Committee Yellow Cover Document (YCD) requirements.A validated stability indicating high-performance liquid chromatography method was used for assessing the stability of the solutions of piperacillin/tazobactam at a combined concentration of 25 mg/mL and 90 mg/mL respectively. Solutions were tested in two batches in replicate (n=3) at five time points according to the requirements of the YCD.ResultsPiperacillin/tazobactam stability was significantly improved when 0.3% w/v citrate-buffered saline pH 7 was used as the diluent, compared with using 0.9% w/v saline as diluent. Greater than 95% of the zero-time concentration of both actives remained following storage at 2°C–8°C for up to 13 days plus 24 hours at 32°C in both devices. The data support extended storage of up to 13 days 2°C–8°C plus 24 hours at 32°C ‘in-use’ when using FOLFusor LV10 (Baxter) or Easypump II (B. Braun) pump devices.ConclusionsThe enhanced stability complies with UK national standards as stated in the YCD for stability testing of aseptically produced small molecules and supports the storage of piperacillin/tazobactam for up to 13 days 2°C–8°C plus 24 hours at 32°C ‘in-use’ within two elastomeric pump devices. The extended shelf-life provides a significant advantage over the stability of piperacillin/tazobactam solutions for infusion when reconstituted and diluted in 0.9% w/v saline as diluent. The data open up the possibility of a continuous infusion of piperacillin/tazobactam delivered by elastomeric pump devices over 24 hours in an outpatient parenteral antimicrobial therapy setting.
Keywords: EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002340
Issue No: Vol. 29, No. 4 (2022)
- Incidence and associated risk factors of antituberculosis drug-induced
hepatotoxicity among hospitalised patients in Wuhan, China-
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Authors:
Xu, N; Yang, J. X, Yang, J.
Pages: 217 - 221
Abstract: ObjectiveTo analyse the incidence and risk factors of hepatotoxicity induced by antituberculosis (anti-TB) drugs in Renmin Hospital of Wuhan University, and to provide evidence for clinical prevention and treatment of anti-TB drug damage.MethodsA retrospective analysis of patients who received first-line anti-TB drugs from January 2016 to December 2018 in Renmin Hospital of Wuhan University was conducted. Univariate analysis and binary logistic regression analysis with the forward stepwise method were used to assess the risk factors associated with hepatotoxicity induced by anti-TB drugs.ResultsOf the 1603 patients treated with anti-TB drugs, only 1115 patients met the inclusion criteria and 42 subjects developed anti-TB drug-induced hepatotoxicity (ATDH). Significant differences (p
Keywords: EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002433
Issue No: Vol. 29, No. 4 (2022)
- Long-term effectiveness and pharmacokinetics of the infliximab biosimilar
CT-P13 after switching from the originator during the treatment of
inflammatory bowel disease-
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Authors:
Martin-Gutierrez, N; Sanchez-Hernandez, J. G, Rebollo, N, Pordomingo, A. F, Munoz, F, Otero, M. J.
Pages: 222 - 227
Abstract: ObjectiveSwitching patients from the originator infliximab to a biosimilar is a measure to expand access to treatments and counteract its negative impact on healthcare budgets. However, industry-independent long-term studies on the effect of switching in real life to support the lack of switch-related problems in inflammatory bowel disease (IBD) patients are sparse, as are studies addressing infliximab pharmacokinetic behaviour. The objectives were to investigate the effectiveness and the pharmacokinetics of CT-P13 after switching from originator infliximab in a real-world population of IBD patients with a follow-up of 2 years.MethodProspective, single-centre, observational 2 year study conducted in IBD adult patients with stable disease treated with the originator infliximab who were switched to CT-P13. Four time points were defined for follow-up: prior to the switch, 4–8 weeks after the switch, 8 months later, and 2 years later. Outcome measures were the proportion of patients with clinical, endoscopic and biochemical remission, and changes in biochemical inflammation markers (albumin, C-reactive protein, faecal calprotectin) and infliximab clearance.Results42 IBD patients were switched, of which 36 (85.7%) remained on CT-P13 throughout the 2 year study period. Only two patients discontinued CT-P13 due to loss of response. The proportion of patients who displayed clinical, endoscopic and biochemical remission were unchanged during the follow-up (p
Keywords: EAHP Statement 4: Clinical Pharmacy Services
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002410
Issue No: Vol. 29, No. 4 (2022)
- High concentrated etoposide solutions, additional physical stability data
in dextrose 5%-
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Authors:
Ravey, M; Polo, C, D'Huart, E, Vigneron, J, Demore, B.
Pages: 228 - 230
Abstract: ObjectivesAccording to the manufacturers, the concentration of etoposide solutions should not exceed 0.4 mg/mL due to a risk of precipitation. Stability studies at higher concentrations were conducted and notably demonstrated 28 day stability up to 1.75 mg/mL for etoposide solutions in 5% dextrose (D5W). Nevertheless, colleagues report precipitation even at 0.4 mg/mL in their daily practice. The objective of this work was to reassess the physical stability of highly concentrated etoposide solutions in D5W (1.2 mg/mL), over a large number of preparations and under different manufacturing processes.MethodsTo study the impact of manufacturing process, etoposide was taken with a spike or a needle and injected in three types of D5W containers (Easyflex, Viaflo and Ecoflac). Forty preparations were made for each container. For half of the preparations, a homogenisation was performed by a syringe rinse. Physical stability was realised by two examiners, with a visual examination searching for the appearance of a precipitate, daily during the first week, then twice a week until day 56.ResultsHundred and eighteen solutions were clear and colourless. Precipitates were observed for two solutions: one in an Easyflex bag on day 4 and one in an Ecoflac container on day 35.ConclusionsThe physical stability at 1.2 mg/mL in D5W remains validated. Precipitations are rare and concern less than 2% of preparations. The appearance of a precipitate does not seem to be correlated to the kind of container or manufacturing process. A rinse was performed for these two solutions to assess a mechanical pressure effect more important on the solution, which could lead to a higher risk of precipitations. However, this is not observed in our daily practice, especially at lower concentrated solutions. We only recommend using an administration set with an in-line micro-filter as a precaution in case of precipitations.
Keywords: EAHP Statement 3: Production and Compounding
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002468
Issue No: Vol. 29, No. 4 (2022)
- Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome in a
paediatric patient taking zonisamide-
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Authors:
Trivedi, A; Sharma, S, Govindan, R.
Pages: 231 - 234
Abstract: We describe the case of an 11-year-old male patient who presented with a new onset of rash after a recent introduction of zonisamide. Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) is a very serious but rare adverse effect of anticonvulsants such as carbamazepine and phenytoin; however, the reported incidence on zonisamide is scant. DRESS syndrome is complex in its presentation. This patient presented with rash, fever, lymphadenopathy, severe skin erythema, oedema and reduced Glasgow Coma Scale (GCS). He was successfully treated with pulsed intravenous methylprednisolone and intravenous immunoglobulin. The patient was discharged home well after a 3-week admission.
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002387
Issue No: Vol. 29, No. 4 (2022)
- Administration of benralizumab in a patient with severe asthma admitted to
the intensive care unit with COVID-19 pneumonia: case report-
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Authors:
Kroes, J. A; Zielhuis, S. W, Bethlehem, C, Ten Brinke, A, Van Roon, E. N.
Pages: 235 - 236
Abstract: A patient with severe asthma on benralizumab therapy was admitted to the intensive care unit (ICU) for a coronavirus disease 2019 (COVID-19) infection. At the end of the 8 week benralizumab dosing interval, discussion arose as to whether benralizumab should be administered or if treatment should be discontinued, due to the lack of experience with benralizumab in this situation. Severe broncho-obstruction developed, and the next injection of benralizumab was administered during ICU admission without detrimental symptoms. With this case report, we would like to share our experience with the safe administration of benralizumab during COVID-19 pneumonia, guiding doctors in future decision making.
Keywords: Open access, COVID-19
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002660
Issue No: Vol. 29, No. 4 (2022)
- Is it safe to use visible blue light-emitting diode phototherapy for
neonatal jaundice in infants who are also treated with amiodarone'-
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Authors:
Morris, S; Shaw, A.
Pages: 237 - 238
Abstract: Amiodarone is a useful treatment for neonatal cardiac arrhythmias. A minority of neonates with arrhythmias treated with amiodarone may also develop neonatal jaundice. Phototherapy is recommended to treat neonatal jaundice. However, amiodarone is known to cause skin reactions when patients are exposed to light. Therefore phototherapy may not be administered due to concerns about this interaction. Exchange transfusions are used as an alternative to phototherapy to avoid the interaction. However, exchange transfusions are associated with serious complications such as the transmission of bloodborne disease, seizures and haemodynamic instability. We report a literature review and outcome of a premature infant treated with amiodarone and visible blue light-emitting diode (LED) phototherapy. Phototherapy was used for 54 hours and no skin reactions were observed. This is because visible blue LED phototherapy lamps emit predominantly visible light. Therefore exposure to ultraviolet light that is known to cause amiodarone phototoxicity is minimised.
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2020-002352
Issue No: Vol. 29, No. 4 (2022)
- Roberto Frontini appointed as a member of PRAC
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Authors:
Kohl; S.
Pages: 239 - 240
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2022-003412
Issue No: Vol. 29, No. 4 (2022)
- European health data space proposal launched
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Authors:
Kohl; S.
Pages: 240 - 240
PubDate: 2022-06-23T01:03:21-07:00
DOI: 10.1136/ejhpharm-2022-003413
Issue No: Vol. 29, No. 4 (2022)
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