Strategic Partnerships in Pharmacovigilance: Business, Legal, and Regulatory Domains
Clin Ther. 2024 Apr 26:S0149-2918(24)00074-2. doi: 10.1016/j.clinthera.2024.03.007. Online ahead of print.ABSTRACTPharmaceutical development is a highly regulated industry through numerous worldwide guidance, laws, and regulations. Issues related to the safety of pharmaceutical products have been the most common cause of withdrawals from the market, as well as restrictions on distribution and limitations on labeling. Collaboration (hereafter referred to as partnership) between pharmaceutical companies in drug development has been recognized as critically significant to maximize the efficiency of drug development. In genera...
Source: Clinical Therapeutics - April 27, 2024 Category: Drugs & Pharmacology Authors: Ashraf Youssef Nancy L Blanchard Tarek A Hammad Source Type: research
Lessons Learned From Clinical Studies in Centronuclear Myopathies: The Patient Perspective-A Qualitative Study
CONCLUSION: The acknowledgment and inclusion of patients' perspectives and efficient and effective communication is expected to improve patient recruitment and retention in future clinical studies, as well as more accurate assessment of the patient performance related to suitable planning of the study visits.PMID:38670885 | DOI:10.1016/j.clinthera.2024.03.008 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - April 26, 2024 Category: Drugs & Pharmacology Authors: Lizan Stinissen Johann B öhm Sietse Bouma Jeno van Tienen Holger Fischer Zak Hughes Anne Lennox Erin Ward Marie Wood A Reghan Foley Wija Oortwijn Heinz Jungbluth Nicol C Voermans Source Type: research
Spinal Muscular Atrophy: Expanded Access as an Instrument of Fairness
Clin Ther. 2024 Apr 25:S0149-2918(24)00076-6. doi: 10.1016/j.clinthera.2024.03.010. Online ahead of print.NO ABSTRACTPMID:38670886 | DOI:10.1016/j.clinthera.2024.03.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - April 26, 2024 Category: Drugs & Pharmacology Authors: Paul Beninger Source Type: research
Knowledge Graphs in Pharmacovigilance: A Step-By-Step Guide
Clin Ther. 2024 Apr 25:S0149-2918(24)00071-7. doi: 10.1016/j.clinthera.2024.03.006. Online ahead of print.ABSTRACTPURPOSE: This work aims to demystify Knowledge Graphs (KGs) in pharmacovigilance (PV). It complements the scoping review within this issue. By bridging knowledge gaps and stimulating interest, further engagement with this topic by pharmacovigilance professionals will be facilitated.METHODS: We elucidate fundamental KGs concepts and terminology, followed by delineating a sequence of implementation steps: use case definition, data type selection, data sourcing, KG construction, KG embedding, and deriving actionab...
Source: Clinical Therapeutics - April 26, 2024 Category: Drugs & Pharmacology Authors: Manfred Hauben Mazin Rafi Source Type: research
Evaluation of Insulin Dosing Strategies for Hyperkalemia Management at an Academic Medical Center
Clin Ther. 2024 Apr 8:S0149-2918(24)00070-5. doi: 10.1016/j.clinthera.2024.03.003. Online ahead of print.ABSTRACTPURPOSE: While intravenous (IV) insulin is often administered at a fixed dose of 10 units for acute hyperkalemia, optimal dosing for minimizing hypoglycemia while effectively reversing hyperkalemia has not been established. The purpose of this analysis was to evaluate the effect of insulin dosing strategies on hypoglycemia in patients with hyperkalemia.METHODS: Adult patients presenting to an academic medical center who received IV insulin for hyperkalemia between 2016 and 2020 were retrospectively identified. P...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Meghan E Cook Lena K Tran Jeremy R DeGrado Afrah Alkazemi Kaylee K Marino Source Type: research
The Effects of L-Carnitine Supplementation on Weight Loss, Glycemic Control, and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Systematic Review and Dose-Response Meta-Analysis of Randomized Controlled Trials
Clin Ther. 2024 Apr 8:S0149-2918(24)00068-7. doi: 10.1016/j.clinthera.2024.03.002. Online ahead of print.ABSTRACTPURPOSE: L-carnitine supplementation has been recommended to improve cardiometabolic health markers in diabetic patients. Our purpose was to assess the dose-dependent effects of l-carnitine supplementation on cardiometabolic risk factors in patients with type 2 diabetes.METHODS: PubMed/Medline, Scopus, and Web of Science were searched until May 2022 for randomized controlled trials that examined the impact of l-carnitine supplementation on cardiometabolic risk factors in adults with type 2 diabetes. The mean dif...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Amin Mirrafiei Ahmad Jayedi Sakineh Shab-Bidar Source Type: research
Evaluation of Insulin Dosing Strategies for Hyperkalemia Management at an Academic Medical Center
Clin Ther. 2024 Apr 8:S0149-2918(24)00070-5. doi: 10.1016/j.clinthera.2024.03.003. Online ahead of print.ABSTRACTPURPOSE: While intravenous (IV) insulin is often administered at a fixed dose of 10 units for acute hyperkalemia, optimal dosing for minimizing hypoglycemia while effectively reversing hyperkalemia has not been established. The purpose of this analysis was to evaluate the effect of insulin dosing strategies on hypoglycemia in patients with hyperkalemia.METHODS: Adult patients presenting to an academic medical center who received IV insulin for hyperkalemia between 2016 and 2020 were retrospectively identified. P...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Meghan E Cook Lena K Tran Jeremy R DeGrado Afrah Alkazemi Kaylee K Marino Source Type: research
The Effects of L-Carnitine Supplementation on Weight Loss, Glycemic Control, and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Systematic Review and Dose-Response Meta-Analysis of Randomized Controlled Trials
Clin Ther. 2024 Apr 8:S0149-2918(24)00068-7. doi: 10.1016/j.clinthera.2024.03.002. Online ahead of print.ABSTRACTPURPOSE: L-carnitine supplementation has been recommended to improve cardiometabolic health markers in diabetic patients. Our purpose was to assess the dose-dependent effects of l-carnitine supplementation on cardiometabolic risk factors in patients with type 2 diabetes.METHODS: PubMed/Medline, Scopus, and Web of Science were searched until May 2022 for randomized controlled trials that examined the impact of l-carnitine supplementation on cardiometabolic risk factors in adults with type 2 diabetes. The mean dif...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Amin Mirrafiei Ahmad Jayedi Sakineh Shab-Bidar Source Type: research
Evaluation of Insulin Dosing Strategies for Hyperkalemia Management at an Academic Medical Center
Clin Ther. 2024 Apr 8:S0149-2918(24)00070-5. doi: 10.1016/j.clinthera.2024.03.003. Online ahead of print.ABSTRACTPURPOSE: While intravenous (IV) insulin is often administered at a fixed dose of 10 units for acute hyperkalemia, optimal dosing for minimizing hypoglycemia while effectively reversing hyperkalemia has not been established. The purpose of this analysis was to evaluate the effect of insulin dosing strategies on hypoglycemia in patients with hyperkalemia.METHODS: Adult patients presenting to an academic medical center who received IV insulin for hyperkalemia between 2016 and 2020 were retrospectively identified. P...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Meghan E Cook Lena K Tran Jeremy R DeGrado Afrah Alkazemi Kaylee K Marino Source Type: research
The Effects of L-Carnitine Supplementation on Weight Loss, Glycemic Control, and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Systematic Review and Dose-Response Meta-Analysis of Randomized Controlled Trials
Clin Ther. 2024 Apr 8:S0149-2918(24)00068-7. doi: 10.1016/j.clinthera.2024.03.002. Online ahead of print.ABSTRACTPURPOSE: L-carnitine supplementation has been recommended to improve cardiometabolic health markers in diabetic patients. Our purpose was to assess the dose-dependent effects of l-carnitine supplementation on cardiometabolic risk factors in patients with type 2 diabetes.METHODS: PubMed/Medline, Scopus, and Web of Science were searched until May 2022 for randomized controlled trials that examined the impact of l-carnitine supplementation on cardiometabolic risk factors in adults with type 2 diabetes. The mean dif...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Amin Mirrafiei Ahmad Jayedi Sakineh Shab-Bidar Source Type: research
Evaluation of Insulin Dosing Strategies for Hyperkalemia Management at an Academic Medical Center
Clin Ther. 2024 Apr 8:S0149-2918(24)00070-5. doi: 10.1016/j.clinthera.2024.03.003. Online ahead of print.ABSTRACTPURPOSE: While intravenous (IV) insulin is often administered at a fixed dose of 10 units for acute hyperkalemia, optimal dosing for minimizing hypoglycemia while effectively reversing hyperkalemia has not been established. The purpose of this analysis was to evaluate the effect of insulin dosing strategies on hypoglycemia in patients with hyperkalemia.METHODS: Adult patients presenting to an academic medical center who received IV insulin for hyperkalemia between 2016 and 2020 were retrospectively identified. P...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Meghan E Cook Lena K Tran Jeremy R DeGrado Afrah Alkazemi Kaylee K Marino Source Type: research
The Effects of L-Carnitine Supplementation on Weight Loss, Glycemic Control, and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Systematic Review and Dose-Response Meta-Analysis of Randomized Controlled Trials
Clin Ther. 2024 Apr 8:S0149-2918(24)00068-7. doi: 10.1016/j.clinthera.2024.03.002. Online ahead of print.ABSTRACTPURPOSE: L-carnitine supplementation has been recommended to improve cardiometabolic health markers in diabetic patients. Our purpose was to assess the dose-dependent effects of l-carnitine supplementation on cardiometabolic risk factors in patients with type 2 diabetes.METHODS: PubMed/Medline, Scopus, and Web of Science were searched until May 2022 for randomized controlled trials that examined the impact of l-carnitine supplementation on cardiometabolic risk factors in adults with type 2 diabetes. The mean dif...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Amin Mirrafiei Ahmad Jayedi Sakineh Shab-Bidar Source Type: research
Evaluation of Insulin Dosing Strategies for Hyperkalemia Management at an Academic Medical Center
Clin Ther. 2024 Apr 8:S0149-2918(24)00070-5. doi: 10.1016/j.clinthera.2024.03.003. Online ahead of print.ABSTRACTPURPOSE: While intravenous (IV) insulin is often administered at a fixed dose of 10 units for acute hyperkalemia, optimal dosing for minimizing hypoglycemia while effectively reversing hyperkalemia has not been established. The purpose of this analysis was to evaluate the effect of insulin dosing strategies on hypoglycemia in patients with hyperkalemia.METHODS: Adult patients presenting to an academic medical center who received IV insulin for hyperkalemia between 2016 and 2020 were retrospectively identified. P...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Meghan E Cook Lena K Tran Jeremy R DeGrado Afrah Alkazemi Kaylee K Marino Source Type: research
The Effects of L-Carnitine Supplementation on Weight Loss, Glycemic Control, and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Systematic Review and Dose-Response Meta-Analysis of Randomized Controlled Trials
Clin Ther. 2024 Apr 8:S0149-2918(24)00068-7. doi: 10.1016/j.clinthera.2024.03.002. Online ahead of print.ABSTRACTPURPOSE: L-carnitine supplementation has been recommended to improve cardiometabolic health markers in diabetic patients. Our purpose was to assess the dose-dependent effects of l-carnitine supplementation on cardiometabolic risk factors in patients with type 2 diabetes.METHODS: PubMed/Medline, Scopus, and Web of Science were searched until May 2022 for randomized controlled trials that examined the impact of l-carnitine supplementation on cardiometabolic risk factors in adults with type 2 diabetes. The mean dif...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Amin Mirrafiei Ahmad Jayedi Sakineh Shab-Bidar Source Type: research
Evaluation of Insulin Dosing Strategies for Hyperkalemia Management at an Academic Medical Center
Clin Ther. 2024 Apr 8:S0149-2918(24)00070-5. doi: 10.1016/j.clinthera.2024.03.003. Online ahead of print.ABSTRACTPURPOSE: While intravenous (IV) insulin is often administered at a fixed dose of 10 units for acute hyperkalemia, optimal dosing for minimizing hypoglycemia while effectively reversing hyperkalemia has not been established. The purpose of this analysis was to evaluate the effect of insulin dosing strategies on hypoglycemia in patients with hyperkalemia.METHODS: Adult patients presenting to an academic medical center who received IV insulin for hyperkalemia between 2016 and 2020 were retrospectively identified. P...
Source: Clinical Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Meghan E Cook Lena K Tran Jeremy R DeGrado Afrah Alkazemi Kaylee K Marino Source Type: research
