Generation of a pregnancy cohort for medicine utilisation and medicine safety studies in New Zealand
Sign Up to like & getrecommendations! Published in 2018 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4671
Abstract: The aim of this study was to use national health databases to assemble a pregnancy cohort for undertaking medicine utilisation and safety studies in New Zealand. read more here.
Keywords: medicine; studies new; safety studies; safety ... See more keywords
Approval of modified‐release products by FDA without clinical efficacy/safety studies: A retrospective survey from 2008 to 2017
Sign Up to like & getrecommendations! Published in 2019 at "Regulatory Toxicology and Pharmacology"
DOI: 10.1016/j.yrtph.2019.01.037
Abstract: Abstract In principle, approval of a modified‐release (MR) drug product is based on evidence from pharmacokinetic (PK) and/or pharmacodynamic studies and clinical efficacy/safety studies. The purpose of this survey is (i) to explore the number… read more here.
Keywords: drug; efficacy safety; safety studies; clinical efficacy ... See more keywords
Toxicologic Pathology Forum Opinion: Interpretation of Gliosis in the Brain and Spinal Cord Observed During Nonclinical Safety Studies.
Sign Up to like & getrecommendations! Published in 2023 at "Toxicologic pathology"
DOI: 10.1177/01926233231164557
Abstract: Gliosis, defined as a nonneoplastic reaction (hypertrophy and/or proliferation) of astrocytes and/or microglial cells, is a frequent finding in the central nervous system (CNS [brain and/or spinal cord]) in nonclinical safety studies. Gliosis in rodents… read more here.
Keywords: brain spinal; nonclinical safety; safety studies; pathology ... See more keywords
Safety Studies of Pneumococcal Endolysins Cpl-1 and Pal
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DOI: 10.3390/v10110638
Abstract: Bacteriophage-derived endolysins have gained increasing attention as potent antimicrobial agents and numerous publications document the in vivo efficacy of these enzymes in various rodent models. However, little has been documented about their safety and toxicity… read more here.
Keywords: safety toxicity; studies pneumococcal; safety studies; safety ... See more keywords