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■ Abbreviation / Long Form : PASS / post-authorization safety studies

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Total Number of Papers: 23
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Abbreviation:   PASS  (>> Co-occurring Abbreviation)
Long Form:   post-authorization safety studies
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No. Year Title Co-occurring Abbreviation
2019 Interest of pharmacoepidemiology in pharmacovigilance: Post-authorization safety studies in regulatory pharmacovigilance activity. PRAC
2019 Validity of hospital ICD-10-GM codes to identify acute liver injury in Germany. ALI, CI, PPVs
2018 Challenges of post-authorization safety studies: Lessons learned and results of a French study of fentanyl buccal tablet. AEs, FBT
2018 Phase IV Studies: Some Insights, Clarifications, and Issues. FDA, HTA, PAES, SAP
2017 Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view. ---
2017 Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight. EMA, ENCePP, EU-PAS, PRAC
2017 Postinjection delirium/sedation syndrome in patients with schizophrenia receiving olanzapine long-acting injection: results from a large observational study. AEs, ENCePP, LAI, OR, PDSS
2016 Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England. AEIs, QLAIV, SAEs
2016 Tolerability and safety of Octagam (IVIG): apost-authorization safety analysis of four non-interventional phase IV trials
10  2015 Evaluation of the safety profile of Zolafren, a generic olanzapine formulation, in patients with bipolar disorder: a post-authorization safety study. AEs, BD
11  2015 Metamizole for postoperative pain therapy in 1177 children: A prospective, multicentre, observational, postauthorisation safety study. ADRs, MAP
12  2015 Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union. CAs, DP, ECs, EU, NIS
13  2015 Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance. SCEM
14  2014 Patient data meta-analysis of Post-Authorization Safety Surveillance (PASS) studies of haemophilia A patients treated with rAHF-PFM. ABR, CI, EDs, IPD, PTPs
15  2012 A pathway to improved prospective observational post-authorization safety studies. RCTs
16  2012 Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in 1130 children: results of an European prospective multicenter observational postauthorization safety study (PASS). ADR, AE, HES
17  2012 Web-based intensive monitoring: from passive to active drug surveillance. ---
18  2011 A novel isotonic balanced electrolyte solution with 1% glucose for intraoperative fluid therapy in neonates: results of a prospective multicentre observational postauthorisation safety study (PASS). BS-G1
19  2011 Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. ADRs, EMA, PRAC
20  2010 A novel isotonic-balanced electrolyte solution with 1% glucose for intraoperative fluid therapy in children: results of a prospective multicentre observational post-authorization safety study (PASS). BS-G1
21  2009 Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval. EU-RMP, RR
22  2009 Pharmacovigilance of biopharmaceuticals: challenges remain. ADRs, EU-RMP
23  2008 Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in children: preliminary results of a European Prospective Multicenter Observational Postauthorization Safety Study (PASS). ADRs, HES, PVR