There are multiple exceptions to the general regulatory requirements. These may be based on current scientific understanding of specific products or product classes; or on careful assessment of any risks that may occur with deviation from the normal timelin...
Such evaluation includes a variety of in vitro and in vivo studies that assess safety pharmacology, general toxicity, genotoxicity, carcinogenicity, and developmental and reproductive toxicity. Compliance with good laboratory practice (GLP) regu...
select article Characterization, molecular modeling and pharmacology of some 2́-hydroxychalcone derivatives as SARS-CoV-2 inhibitor Research articleOpen access Characterization, molecular modeling and pharmacology of some 2́-hydroxychalcone derivatives as SARS-CoV-2 inhibitor Mohammad Nasir Uddin, Sayeda...
Systems pharmacology: defining the interactions of drug combinations. Annu. Rev. Pharmacol. Toxicol. 59, 21–40 (2019). PubMed Google Scholar Morphy, R. Selectively nonselective kinase inhibition: striking the right balance. J. Med. Chem. 53, 1413–1437 (2010). CAS PubMed Google Scholar ...
后者非常重要,因为生物技术产品的毒性通常是由引人注目的药理作用而非 "脱靶 "毒性引起的(results from exaggerated pharmacology rather than ‘off-target’ toxicity)。例如,有意抑制免疫功能或促进细胞增殖的产品,如果反应过度,可能会致癌。如果潜在的疾病状态使病人对这些影响更加敏感,情况就更是如此。
This increase in transparency mandates the public dissemination of the results of clinical and pharmacologic trials submitted to the FDA in response to a written request; the FDA Amendments Act of 2007 requires that written requests, as well as medical reviews, clinical pharmacology reviews, and ...
后者非常重要,因为生物技术产品的毒性通常是由引人注目的药理作用而非 "脱靶 "毒性引起的(results from exaggerated pharmacology rather than ‘off-target’ toxicity)。例如,有意抑制免疫功能或促进细胞增殖的产品,如果反应过度,可能会致癌。如果潜在的疾病状态使病人对这些影响更加敏感,情况就更是如此。
FDA. General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry (FDA, 2019). Tozuka, Z. et al. Microdose study of 14C-acetaminophen with accelerator mass spectrometry to examine pharmacokinetics of parent drug and metabolites in healthy subje...
Cancer, a complex and multifactorial disease, presents a significant challenge to global health. Despite significant advances in surgical, radiotherapeutic and immunological approaches, which have improved cancer treatment outcomes, drug therapy continue
G.M. Currie Pharmacology, part 2: introduction to pharmacokinetics J Nucl Med Technol, 46 (2018), pp. 221-230 CrossrefGoogle Scholar 2 R. Yan, Y. Yang, Y. Chen Pharmacokinetics of Chinese medicines: strategies and perspectives Chin Med, 13 (2018), p. 24 View in ScopusGoogle Scholar 3...