Pharmacy Group Journals’ Post

✅️ Pharmacodynamics: Its Role in the Pharmaceutical Industry! From drug interactions to therapeutic effects, learn its role in rational drug design. Join us on LinkedIn to explore the profound impact of pharmacodynamics on drug efficacy and safety. Visit More : https://lnkd.in/gxUWJN4e #pharmacology #pharmacy #pharmaceuticalindustry #chemotherapy #toxicology

https://lnkd.in/gZZpfqdP Article Title: Regarding the measurement of therapeutic adherence Author(s): Sara Malo* Journal: International Journal of Pharmaceutical Sciences and Developmental Research Journal ISSN: 2640-7760 Adherence to chronic therapies among population living in developed countries has been estimated about 50% [1]. This is a matter of concern, since poor adherence is associated with suboptimal clinical outcomes, increased frequency of adverse effects and high healthcare expenses [2]. #MedicinalChemistry #DrugDevelopment #Pharmacokinetics #Pharmacodynamics #Pharmacogenomics #Toxicology #Pharmaceutics #Biopharmaceutics #Pharmacognosy #PharmaceuticalChemistry #PharmacyPractice #CommunityPharmacy #HospitalPharmacy #IndustrialPharmacy #RegulatoryAffairs #DrugFormulation#DrugDelivery #PharmacyManagement #PharmaceuticalTechnology #PharmacyEducation #ClinicalTrials

Nitrosamine Drug Substance-Related Impurities (NDSRIs) are a type of nitrosamine impurity that shares structural similarities with active pharmaceutical ingredients. But here’s the thing: their genotoxic and mutagenic potential has remained largely unknown, raising concerns about safety. This is where a groundbreaking study by Xilin Li and colleagues, published in Regulatory Toxicology and Pharmacology, comes in. They tested 15 different NDSRIs in human TK6 cells to reveal some eye-opening findings about these impurities’ potential risks. Using the Enhanced Ames Test (EAT) and several genotoxicity assays, they found that some NDSRIs pose significant genotoxic risks. Notably, N-nitroso-nortriptyline, N-nitroso-fluoxetine, N-nitroso-desmethyl-diphenhydramine, N-nitroso-duloxetine, N-nitroso-lorcaserin, N-nitroso-varenicline, and N-nitroso-sertraline showed concentration-dependent increases in micronuclei when activated by hamster liver S9 enzymes, a clear sign of genotoxicity. Key enzymes like CYP2C19, CYP2B6, CYP2A6, and CYP3A4 play a crucial role in activating these impurities, essentially turning them into potential hazards. One of the most striking findings? The mutagenicity results obtained in TK6 cells with hamster S9 were consistent with those from the Enhanced Ames Test. This consistency across different testing systems supports the use of the EAT as a reliable tool for assessing the safety and hazard potential of NDSRIs. These insights are a major step forward in understanding the risks posed by nitrosamine impurities in pharmaceuticals, and they underscore the importance of robust testing for drug safety. #Pharmaceuticals #Nitrosamines #Genotoxicity #DrugDevelopment #EnhancedAmesTest #Toxicology #PublicHealth #NDSRIs #Regulatory #FDA #EMA #USP DOI: 10.1016/j.yrtph.2024.105730

(Pharmacovigilance / Liver-Chip for DILI events / US FDA News) For anyone who is on a clinical safety team and evaluating for DILI events or drug-induced liver injury, this would be something new and interesting from US FDA (and seems like this might be a related poster). Beyond that, we're moving to being being able to address drug safety issues on a chip. Enjoy the read and also learn what an iStand proposal is. #fda #cder #drug #cber #biologics #dili #hepatotoxicity #druginducedliverinjury #livertoxicity #pharmacovigilance #drugsafety

https://lnkd.in/gqJAWgZw Article Title: Is it possible to perform molecular hybridization between acetaminophen and nitric oxide donor molecule? Author(s): João Gabriel Gouvêa-Silva, Leonardo Ribeiro Bernardo, Ygor Jessé Ramos* and Antônio José Calixto de Souza Journal: International Journal of Pharmaceutical Sciences and Developmental Research Journal ISSN: 2640-7760 Opinion Paracetamol (Acetaminophen) belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), having an analgesic, antipyretic and mild anti-inflammatory action due to a weak inhibitory action on cyclooxygenase isoenzymes, COX-1 and COX-2. These isoenzymes are responsible for the synthesis of prostanoids that have several physiological effects, such as: vasodilation; increased renal blood flow; stimulation of gastric protective mucus production; inhibition of gastric acid secretion responsible for reducing acidity in gastric tissue, among other effects. Despite its beneficial effects, the excessive use of NSAIDs is related to several adverse effects, which can alter the homeostasis of the cardiovascular, renal and gastric system [1]. #MedicinalChemistry #DrugDevelopment #Pharmacokinetics #Pharmacodynamics #Pharmacogenomics #Toxicology #Pharmaceutics #Biopharmaceutics #Pharmacognosy #PharmaceuticalChemistry #PharmacyPractice #CommunityPharmacy #HospitalPharmacy #IndustrialPharmacy #RegulatoryAffairs #DrugFormulation#DrugDelivery #PharmacyManagement #PharmaceuticalTechnology #PharmacyEducation #ClinicalTrials

Hi Everyone, 💡 Sharing a presentation on "Non-clinical resources and guidance for approaching first in human studies in oncology". 🎯 Key points ➡ Non-clinical aspects and anti-cancer drugs ➡ ICH S9: basic recommendations (28-day GLP compliance tox study in 2 species, For biologics ICH S6 and addendum) ➡ Importance of primary data to determine the starting dose of the human trial (FIH) 🔶 MABEL Approach: Minimally anticipated biological effect level (For biopharmaceuticals with immune agonistic properties); heavily relies on pharmacological studies. 📚 Endpoints for GLP Tox studies #Oncology #Firstinhuman #FIH #FDA #Regulatory #Toxicology #Pharmacology #preclinical #Anticancer #dose #dosing #guidance #resources #USFDA #learning #knowledgesharing #CDER #Clinical #Basics #Literature #Pharmaceuticals #Pharma #NDA #IND #Biologics

Recently, numerous innovative studies have focused on enhancing the Ames test to accurately assess the mutagenic potential of nitrosamines, particularly NDSRIs (Nitrosamine Drug Substance-Related Impurities). Historically, certain nitrosamine compounds showed negative results in the Ames test while exhibiting positive carcinogenic effects in rodent studies, raising concerns about test reliability. In response, initial studies optimized the Ames test parameters, such as pre-incubation time, solvent selection, and hamster liver S9, to improve its sensitivity. Following recommendations from EMA and FDA, criteria were established to increase the test's reliability, specifically by defining positive control compounds like 1-cyclopentyl-4-nitrosopiperazine and specifying solvent volumes. For assessing the mutagenic effects of NDSRIs and small-molecule nitrosamines, using 30% hamster liver S9 and specific bacterial strains (TA1535, WP2 uvrA) provided the most accurate results. Additionally, with the OECD-aligned Ames test, seven previously “false-negative” nitrosamines were reclassified as mutagenic, confirming their compatibility with the Ames test. For compounds like NO-HCTZ, a modified Ames test with added glutathione was developed to isolate the mutagenic effects of byproducts like formaldehyde; ultimately, results showed that NO-HCTZ’s positive test results stemmed from byproducts, not intrinsic mutagenicity. Together, these studies have transformed the Ames test into a crucial tool for reliable assessment of NDSRIs and nitrosamines, providing a new perspective on pharmaceutical safety. #AmesTest #NDSRI #Nitrosamines #Pharmaceuticals #Mutagenicity #Toxicology #FDA #EMA #USP #Genotoxicity #NDMA https://lnkd.in/dPnj3pyq https://lnkd.in/d59hiNSQ https://lnkd.in/dHx88Ek5 https://lnkd.in/dMnHcv4N https://lnkd.in/dcbc4pcF

https://lnkd.in/ga4BpCpz Article Title: The use of pentoxifylline in male reproduction abnormalities Author(s): Aamir Jalal Al-Mosawi* Journal: International Journal of Pharmaceutical Sciences and Developmental Research Journal ISSN: 2640-7760 Abstract: Pentoxifylline a derivative of methylxanthine and nonspecific inhibitor of the phosphodiesterase with vasodilatory properties and rheological properties on blood that made it useful in the treatment of intermittent claudication. Pentoxifylline also has an immunomodulatory effect which inhibits inflammatory cytokines including tumor necrosis factor-alpha. The aim of this paper is to review the uses of pentoxifylline in male reproduction abnormalities. #Pentoxifylline #Male #Reproductiveabnormalities #Therapeuticeffects #MedicinalChemistry #DrugDevelopment #Pharmacokinetics #Pharmacodynamics #Pharmacogenomics #Toxicology #Pharmaceutics #Biopharmaceutics #Pharmacognosy #PharmaceuticalChemistry #PharmacyPractice #CommunityPharmacy #HospitalPharmacy #IndustrialPharmacy #RegulatoryAffairs #DrugFormulation#DrugDelivery #PharmacyManagement #PharmaceuticalTechnology #PharmacyEducation #ClinicalTrials

Drug Delivery Devices Market size was valued at USD 279.36 Million in 2022 and is projected to reach USD 8796.33 Million by 2031, growing at a CAGR of 46.71% from 2022 to 2031 according to a new report by Intellectual Market Insights Research. Request sample Report 👉 https://lnkd.in/du6c42iK Report Focused on Top Companies:   Altaris, LLC  Bayer Hellas AG  Becton, Dickinson and Company  BIOCORP  F. Hoffmann-La Roche Ltd  GSK  Johnson & Johnson  Merck KGaA  Molex  Novartis  Teva Pharmaceuticals  West Pharmaceutical Services AstraZeneca Bayer (Schweiz) AG;  BD;  Becton, Dickinson and Company Boehringer Ingelheim Cambridge Mechatronics Ltd Cariflex PTE Ltd CEMA Technologies CeQur DALI Medical Devices Ltd. DEC HEALTHCARE Doerfer Companies Elcam Medical Envision Scientific F. Hoffmann-La Roche Ltd Gerresheimer GSK H&T Presspart Insulet Corporation Isometric Micro Molding, Inc. Johnson & Dugan Insurance Services, Inc., Kalila Medical (Terumo Medical) Medtronic Monaghan Medical Corporation NEMERA NEUMA by Kymanox Next Breath Noble, An Aptar Pharma Company #drugdelivery #lnp #microagulhamento #pharmaceuticals #therapeutic #vaccine #pharmaceutical #rna #dna #drugmanufacturing #fda #university #lipid #therapeutics #nanoparticle #formulation #commercial #polymernanoparticle #cdmo #mrnavaccines #preclinical #vaccines #mrna #clinical #sterile #pharmaceuticalmanufacturing #sterileprocessing #toxicology #fillandfinish #dermatologia

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