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10.3897/folmed.62.e53742 http://scihub22266oqcxt.onion/10.3897/folmed.62.e53742 33009760!ä!33009760 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Folia+Med+(Plovdiv) 2020 ; 62 (3): 592-596 Nephropedia Template TP {{tp|p=33009760|t=2020. Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19 |pdf=|usr=}}{{33009760}} gab.com Text Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19 JO: Folia Med (Plovdiv) http://www.kidney.de/pget.php?&tw=1&pmid=33009760 #FOAvip INTRODUCTION: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding compassionate use is to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond. AIM: The present short communication aimed to highlight the need for early and expanded access to investigational drugs for compassionate use as well as a call for an update of the existing regulation in Bulgaria concerning compassionate use in the era of COVID-19. MATERIALS AND METHODS: In EU and Bulgaria as well, the legal framework for compassionate use was introduced by Article 83 (1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council; in principle, Regulations of the European Parliament and of the Council are mandatory for all Member States. Remdesivir appears to have a favorable clinical and safety profile, as reported in a case involving patients with severe COVID-19 through a compassionate use programme. RESULTS: The overall probability of clinical improvement observed in 36 of 53 COVID-19 patients received intravenous remdesivir as part of a compassionate use programme was 68% (95% CI 40% to 80%). Thirty two patients (60%) demonstrated at least one adverse event, twelve 12 patients (23%) experienced serious adverse events and seven patients (13%) died. CONCLUSION: The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use. Twit Text FOAVip Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19 ????Folia Med (Plovdiv) http://www.kidney.de/pget.php?&tw=1&pmid=33009760 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33009760 #FOAvip English Wikipedia <ref>{{Cite pmid|33009760}}</ref> Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19 #MMPMID33009760 Dzhafer N; Papathanasiou JV Folia Med (Plovdiv) 2020[Sep]; 62 (3): 592-596 PMID33009760show ga INTRODUCTION: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding compassionate use is to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond. AIM: The present short communication aimed to highlight the need for early and expanded access to investigational drugs for compassionate use as well as a call for an update of the existing regulation in Bulgaria concerning compassionate use in the era of COVID-19. MATERIALS AND METHODS: In EU and Bulgaria as well, the legal framework for compassionate use was introduced by Article 83 (1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council; in principle, Regulations of the European Parliament and of the Council are mandatory for all Member States. Remdesivir appears to have a favorable clinical and safety profile, as reported in a case involving patients with severe COVID-19 through a compassionate use programme. RESULTS: The overall probability of clinical improvement observed in 36 of 53 COVID-19 patients received intravenous remdesivir as part of a compassionate use programme was 68% (95% CI 40% to 80%). Thirty two patients (60%) demonstrated at least one adverse event, twelve 12 patients (23%) experienced serious adverse events and seven patients (13%) died. CONCLUSION: The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use. |Adenosine Monophosphate/*analogs & derivatives/therapeutic use[MESH] |Alanine/*analogs & derivatives/therapeutic use[MESH] |Antiviral Agents/*therapeutic use[MESH] |Betacoronavirus[MESH] |Bulgaria[MESH] |COVID-19[MESH] |COVID-19 Drug Treatment[MESH] |Compassionate Use Trials/*legislation & jurisprudence[MESH] |Coronavirus Infections/*drug therapy[MESH] |Drugs, Investigational[MESH] |Health Policy/*legislation & jurisprudence[MESH] |Humans[MESH] |Pandemics[MESH] |Pneumonia, Viral/*drug therapy[MESH]Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the(epmc).pdf DeepDyve Pubget Overpricing