Saad Shakir
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View article: From a pyramid to an amphitheatre (triangle to circle): embracing the totality of evidence for the postmarketing evaluation of the safety of therapeutic interventions
From a pyramid to an amphitheatre (triangle to circle): embracing the totality of evidence for the postmarketing evaluation of the safety of therapeutic interventions Open
Objectives To propose a novel approach to evidence-based medicine (EBM) for medication safety. To critically evaluate the appropriateness of the traditional pyramid hierarchy of evidence for pharmacovigilance. Key arguments For over three …
View article: Microbiological Analysis of Tissue Paper Pre- and Post-Exposure in Restrooms and its effects to women’s health
Microbiological Analysis of Tissue Paper Pre- and Post-Exposure in Restrooms and its effects to women’s health Open
Back ground and Objectives: Toilet tissue paper are sanitary paper that comes into direct contact with the body but at the same time they are a good place for growth of microorganism. The objective of this study was to isolate, identify an…
View article: Knowledge, Attitude, and Practice of Pharmacy Students Toward Over-the-Counter Drugs
Knowledge, Attitude, and Practice of Pharmacy Students Toward Over-the-Counter Drugs Open
Background: Over-the-counter (OTC) medications are commonly utilized for self-treatment due to their easy accessibility and perceived safety; however, inappropriate use can result in adverse health outcomes. As future healthcare providers,…
View article: Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study
Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study Open
Objectives To monitor the safety and utilisation of AZD1222 under real-world use in the UK. Design A non-interventional post-authorisation active surveillance study. Setting Vaccination sites in the UK. Participants A total of 17 945 parti…
View article: Comparing the effectiveness of pregabalin and duloxetine in the management of neuropathic pain
Comparing the effectiveness of pregabalin and duloxetine in the management of neuropathic pain Open
Background and objective: Neuropathic pain is a type of pain that originates from damage or dysfunction of the somatosensory nervous system. Managing neuropathic pain is a challenging task as it is chronic and has limited treatment options…
View article: Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance
Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance Open
View article: Safety and effectiveness of the anti‐amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer's disease: The pharmacovigilance perspective
Safety and effectiveness of the anti‐amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer's disease: The pharmacovigilance perspective Open
The development of humanized IgG1 anti‐amyloid monoclonal antibodies, such as lecanemab, provides a promising novel treatment pathway with potential disease‐modifying effects for patients with early Alzheimer's disease (AD). Lecanemab, whi…
View article: Evaluation of latent-transforming growth factor beta-binding protein, dopamine and serotonin in patients with chronic epilepsy according to disease type and body mass index
Evaluation of latent-transforming growth factor beta-binding protein, dopamine and serotonin in patients with chronic epilepsy according to disease type and body mass index Open
The study aimed to evaluate some biochemical, immunological, physiological and neurotransmitter variables in chronic epilepsy patients. The study comprised 60 patients with epilepsy and a control group of 30 healthy persons, aged between 1…
View article: Quantitative Measurement of the Direct Public Health Impact of Medicines Withdrawals in Europe: Development of a Modelling Method and Proof‐of‐Concept Study to Estimate the Morbidity and Mortality Prevented by Regulatory Action
Quantitative Measurement of the Direct Public Health Impact of Medicines Withdrawals in Europe: Development of a Modelling Method and Proof‐of‐Concept Study to Estimate the Morbidity and Mortality Prevented by Regulatory Action Open
Purpose Removing medicines from market may benefit public health by preventing adverse drug reactions (ADRs), which should be quantified. This study's aim was to identify a model to quantify the impact of medicines' marketing authorisation…
View article: The public health impact of suspending cyproterone acetate/ ethinylestradiol (Diane-35 and generics) in France: A predictive modelling technique
The public health impact of suspending cyproterone acetate/ ethinylestradiol (Diane-35 and generics) in France: A predictive modelling technique Open
Purpose : To predict the public health impact of marketing authorisation suspension of cyproterone acetate/ ethinylestradiol (Diane-35 and its generics) in France using a novel modelling technique, and to critique the model. Methods : Cypr…
View article: Case-level causality assessment methodologies, their application, utility, and limitations in determining possible adverse drug reaction: A Scoping review protocol
Case-level causality assessment methodologies, their application, utility, and limitations in determining possible adverse drug reaction: A Scoping review protocol Open
View article: The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance
The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance Open
View article: Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose
Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose Open
View article: Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial
Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial Open
View article: Correction to: Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data
Correction to: Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data Open
View article: Remission rates following deep TMS for treatment-resistant OCD
Remission rates following deep TMS for treatment-resistant OCD Open
Background: Deep TMS was demonstrated to be efficacious for treatment-resistant OCD in sham-controlled pilot and subsequent multicenter trials. More recently, it’s efficacy has also been demonstrated in real-world clinical practice setting…
View article: Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data
Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data Open
View article: Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination
Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination Open
Objectives To determine whether spontaneous reporting rates of myocarditis and pericarditis differed in immunocompromised patients compared with the whole population overall, and in terms of demographics, vaccine dose and time-to-onset. De…
View article: Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature
Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature Open
Objectives To combine spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 messenger RNA (mRNA) vaccines. Design Systematic r…
View article: Long-term outcomes of a course of deep TMS for treatment-resistant OCD
Long-term outcomes of a course of deep TMS for treatment-resistant OCD Open
After a multicenter randomized sham-controlled trial of Deep TMS™ therapy for obsessive-compulsive disorder (OCD) demonstrated a 38% response rate that is sustained for at least four weeks [[1]Carmi L. Tendler A. Bystritsky A. et al.Effica…
View article: Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination
Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination Open
Objectives To determine whether spontaneous reporting rates of myocarditis and pericarditis differed in immunocompromised patients compared to the whole population overall, and in terms of demographics, vaccine dose, and time-to-onset. Des…
View article: P41 Pseudomonas aeruginosa: burden, treatment and outcomes in a long term ventilation service
P41 Pseudomonas aeruginosa: burden, treatment and outcomes in a long term ventilation service Open
Introduction Pseudomonas aeruginosa (PA) is a significant respiratory pathogen but is not well described in patients requiring long term ventilation (LTV). Whilst national guidance exists for the management of PA in the bronchiectasis popu…
View article: Reports of myocarditis and pericarditis following mRNA COVID-19 vaccines: A systematic review of spontaneously reported data from the UK, Europe, and the US and of the literature
Reports of myocarditis and pericarditis following mRNA COVID-19 vaccines: A systematic review of spontaneously reported data from the UK, Europe, and the US and of the literature Open
Objectives To bring together spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 mRNA vaccines. Design Systematic review of …
View article: The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology
The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology Open
View article: What Is the Difference Between Observed Association and Causal Association, Signals and Evidence? Examples Related to COVID-19
What Is the Difference Between Observed Association and Causal Association, Signals and Evidence? Examples Related to COVID-19 Open
OPINION article Front. Pharmacol., 29 January 2021Sec. Drugs Outcomes Research and Policies Volume 11 - 2020 | https://doi.org/10.3389/fphar.2020.569189
View article: Assessing Case Fatality and the Effect of Treatment on Cases of Thrombosis With Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca in the United Kingdom
Assessing Case Fatality and the Effect of Treatment on Cases of Thrombosis With Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca in the United Kingdom Open
View article: Challenges for Drug Repurposing in the COVID-19 Pandemic Era
Challenges for Drug Repurposing in the COVID-19 Pandemic Era Open
The coronavirus disease (COVID-19) pandemic has affected an estimated 16 million persons and caused 0.6 million deaths worldwide by September 2020. The pandemic has led to a rush to repurpose existing drugs, although the underlying evidenc…
View article: Real-world efficacy of deep TMS for obsessive-compulsive disorder: Post-marketing data collected from twenty-two clinical sites
Real-world efficacy of deep TMS for obsessive-compulsive disorder: Post-marketing data collected from twenty-two clinical sites Open
In real-world clinical practice, the majority of OCD patients benefitted from dTMS, and the onset of improvement usually occurs within 20 sessions. Extending the treatment course beyond 29 sessions results in continued reduction of OCD sym…
View article: Deep TMS for major depression, interim post-marketing analysis of 1040 patients.
Deep TMS for major depression, interim post-marketing analysis of 1040 patients. Open
View article: Real-world efficacy of deep TMS for obsessive-compulsive disorder: interim post-marketing analysis of 192 patients from twenty-two sites
Real-world efficacy of deep TMS for obsessive-compulsive disorder: interim post-marketing analysis of 192 patients from twenty-two sites Open
Background: Deep transcranial magnetic stimulation (dTMS) with the H7-coil was FDA cleared for obsessive-compulsive disorder (OCD) in August 2018 based on multicenter sham-controlled studies but the efficacy in real world practices is not …