These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
144 related articles for article (PubMed ID: 29199066)
21. A translational pharmacology approach to understanding the predictive value of abuse potential assessments. Horton DB; Potter DM; Mead AN Behav Pharmacol; 2013 Sep; 24(5-6):410-36. PubMed ID: 23873088 [TBL] [Abstract][Full Text] [Related]
22. Principles of laboratory assessment of drug abuse liability and implications for clinical development. Carter LP; Griffiths RR Drug Alcohol Depend; 2009 Dec; 105 Suppl 1():S14-25. PubMed ID: 19443137 [TBL] [Abstract][Full Text] [Related]
23. Safety Evaluation of CNS Administered Biologics-Study Design, Data Interpretation, and Translation to the Clinic. Vuillemenot BR; Korte S; Wright TL; Adams EL; Boyd RB; Butt MT Toxicol Sci; 2016 Jul; 152(1):3-9. PubMed ID: 27354708 [TBL] [Abstract][Full Text] [Related]
24. Preclinical cardiovascular safety evaluations of biologics: optimizing the approach and follow-up. Hondeghem L; De Clerck F BioDrugs; 2012 Oct; 26(5):275-82. PubMed ID: 22909102 [TBL] [Abstract][Full Text] [Related]
25. Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges. Brennan FR; Andrews L; Arulanandam AR; Blumel J; Fikes J; Grimaldi C; Lansita J; Loberg LI; MacLachlan T; Milton M; Parker S; Tibbitts J; Wolf J; Allamneni KP Regul Toxicol Pharmacol; 2018 Oct; 98():98-107. PubMed ID: 30026135 [TBL] [Abstract][Full Text] [Related]
26. Mechanisms of adverse drug reactions to biologics. Clarke JB Handb Exp Pharmacol; 2010; (196):453-74. PubMed ID: 20020272 [TBL] [Abstract][Full Text] [Related]
27. Principles of assessment of abuse liability: US legal framework and regulatory environment. Rocha BA Behav Pharmacol; 2013 Sep; 24(5-6):403-9. PubMed ID: 23820327 [TBL] [Abstract][Full Text] [Related]
29. Safety assessment of immunomodulatory biologics: the promise and challenges of regulatory T-cell modulation. Ponce RA J Immunotoxicol; 2011; 8(4):389-97. PubMed ID: 21913866 [TBL] [Abstract][Full Text] [Related]
30. T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation. Jawa V; Cousens LP; Awwad M; Wakshull E; Kropshofer H; De Groot AS Clin Immunol; 2013 Dec; 149(3):534-55. PubMed ID: 24263283 [TBL] [Abstract][Full Text] [Related]
32. Assessing the impact of abuse-deterrent opioids (ADOs): identifying epidemiologic factors related to new entrants with low population exposure. Roland CL; Setnik B; Brown DA Postgrad Med; 2017 Jan; 129(1):12-21. PubMed ID: 27960575 [TBL] [Abstract][Full Text] [Related]
35. Differences between post-authorization adverse drug reactions of biopharmaceuticals and small molecules. Ebbers HC; Al-Temimi E; Moors EH; Mantel-Teeuwisse AK; Schellekens H; Leufkens HG BioDrugs; 2013 Apr; 27(2):167-74. PubMed ID: 23400874 [TBL] [Abstract][Full Text] [Related]
36. Identifying appropriate subjects for abuse liability studies using prestudy pharmacological testing. Busto UE; Zawertailo LA; Kaplan HL; Sellers EM Can J Clin Pharmacol; 1999; 6(2):103-10. PubMed ID: 10519736 [TBL] [Abstract][Full Text] [Related]
37. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Ahmed I; Kaspar B; Sharma U Clin Ther; 2012 Feb; 34(2):400-19. PubMed ID: 22244050 [TBL] [Abstract][Full Text] [Related]
38. Recommendations for safety pharmacology evaluations of oligonucleotide-based therapeutics. Berman CL; Cannon K; Cui Y; Kornbrust DJ; Lagrutta A; Sun SZ; Tepper J; Waldron G; Younis HS Nucleic Acid Ther; 2014 Aug; 24(4):291-301. PubMed ID: 24946015 [TBL] [Abstract][Full Text] [Related]
39. Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Sarpatwari A; Gagne JJ; Levidow NL; Kesselheim AS Drug Saf; 2017 Feb; 40(2):105-108. PubMed ID: 27838823 [TBL] [Abstract][Full Text] [Related]