Practical and Regulatory Considerations of Teleprescribing via CVT
Sign Up to like & getrecommendations! Published in 2019 at "Current Psychiatry Reports"
DOI: 10.1007/s11920-019-1073-5
Abstract: Clinical video teleconferencing (CVT) represents a robust mechanism for more accessible medical care. Providers who practice medicine via CVT, including teleprescribing, should understand a number of core practical and regulatory factors. This paper aims to… read more here.
Keywords: via cvt; cvt; considerations teleprescribing; practical regulatory ... See more keywords
Ethical and Regulatory Considerations of Placental Therapeutics.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical therapeutics"
DOI: 10.1016/j.clinthera.2021.01.003
Abstract: PURPOSE Placental therapeutics aim to treat placental disease; however, ethical and regulatory issues should be considered if the drug also potentially affects the fetus. Drugs that might transfer or edit genes carry a specific challenge… read more here.
Keywords: ethical regulatory; placental therapeutics; therapeutics ethical; regulatory considerations ... See more keywords
Peptide-based therapeutics: quality specifications, regulatory considerations, and prospects.
Sign Up to like & getrecommendations! Published in 2019 at "Drug discovery today"
DOI: 10.1016/j.drudis.2018.10.002
Abstract: Exquisite selectivity, remarkable efficacy, and minimal toxicity are key attributes inherently assigned to peptides, resulting in increased research interest from the pharmaceutical industry in peptide-based therapeutics (PbTs). Pharmacopoeias develop authoritative standards for PbT by providing… read more here.
Keywords: specifications regulatory; based therapeutics; peptide based; therapeutics quality ... See more keywords
Regulatory considerations for artificial intelligence technologies in GI endoscopy.
Sign Up to like & getrecommendations! Published in 2020 at "Gastrointestinal endoscopy"
DOI: 10.1016/j.gie.2020.05.040
Abstract: Artificial intelligence (AI) technologies in clinical medicine have become the subject of intensive investigative efforts and popular attention. In domains ranging from pathology to radiology, AI has demonstrated the potential to improve clinical performance and… read more here.
Keywords: endoscopy regulatory; gastroenterology; regulatory considerations; artificial intelligence ... See more keywords
A Guide to Approaching Regulatory Considerations for Lentiviral-Mediated Gene Therapies
Sign Up to like & getrecommendations! Published in 2017 at "Human Gene Therapy Methods"
DOI: 10.1089/hgtb.2017.096
Abstract: Lentiviral vectors are increasingly the gene transfer tool of choice for gene or cell therapies, with multiple clinical investigations showing promise for this viral vector in terms of both safety and efficacy. The third-generation vector… read more here.
Keywords: gene therapy; guide approaching; approaching regulatory; gene ... See more keywords
Regulatory considerations, challenges and risk-based approach in nanomedicine development.
Sign Up to like & getrecommendations! Published in 2021 at "Current medicinal chemistry"
DOI: 10.2174/0929867328666210406115529
Abstract: The translation of nanomedicines from the lab level into marketed product face several challenges including characterization of physicochemical properties, pharmacodynamics, pharmacokinetics, process control, biocompatibility and nanotoxicity, scale-up as well as reproducibility. The challenges of nanomedicine… read more here.
Keywords: quality; nanomedicine development; regulatory considerations; risk based ... See more keywords
Regulatory considerations for generic products of non-biological complex drugs
Sign Up to like & getrecommendations! Published in 2023 at "Journal of Food and Drug Analysis"
DOI: 10.38212/2224-6614.3441
Abstract: The Non-Biological Complex Drug (NBCD) Working Group defines an NBCD as “a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and… read more here.
Keywords: generic products; considerations generic; regulatory considerations; follow versions ... See more keywords