References
- Briscoe CJ , HageDS. Factors affecting the stability of drugs and drug metabolites in biological matrices. Bioanalysis1 (1), 205–220 (2009).
- The expanding field of antibody-drug conjugate. https://adcreview.com/news/expanding-field-antibody-drug-conjugates/.
- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Immunogenicity testing of therapeutic protein products – developing and validating assays for anti-drug antibody detection guidance for industry (2019). https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm629728.pdf.
- Thirty years of innovation pays off as oligonucleotide therapeutics come to market. https://medicalxpress.com/news/2018-01-years-oligonucleotide-therapeutics.html.
- Xu L , AnchordoquyT. Drug delivery trends in clinical trials and translational medicine: challenges and opportunities in the delivery of nucleic acid-based therapeutics. J. Pharm. Sci.100 (1), 38–52 (2011).
- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Bioanalytical method validation guidance for industry (2018). https://www.fda.gov/downloads/drugs/guidances/ucm070107.pdf.
- US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM). Guidance for industry bioanalytical method validation (2001).
- Freisleben A , Brudny KlöppelM, MulderH, de VriesR, de ZwartM, TimmermanP. Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis. Bioanalysis3 (12), 1333–1336 (2011).
- Ginny J , ElizabethP, CurtisES, ChrisK, ElliotO. Unexpected results for sample collection and handling stability assessment for sumatriptan in human plasma. Presented at : WRIB, Montreal, QC, Canada, April, 2013. https://www.celerion.com/wp-content/uploads/2013/04/Celerion_WRIB_040913_Unexpected-Results-for-Sample-Collection.pdf.
- Redrup MJ , IgarashiH, SchaefgenJet al. Sample management: recommendation for best practices and harmonization from the global Bioanalysis Consortium Harmonization Team. AAPS J.18 (2), 290–293 (2016).
- Hilhorst M , van AmsterdamP, HeinigK, ZwanzigerE, AbbottR. Stabilization of clinical samples collected for quantitative bioanalysis – a reflection from the European Bioanalysis Forum. Bioanalysis7 (3), 333–343 (2015).
- Notice: Clarification of Bioanalytical Method Validation Procedures. Health Canada, Bureau of Pharmaceutical Sciences Therapeutic Products Directorate, ON, Canada (2015). https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-clarification-bioanalytical-method-validation-procedures.html.
- Addendum to Notice: Clarification of Bioanalytical Method Validation Procedures. Health Canada, Bureau of Pharmaceutical Sciences Therapeutic Products Directorate, ON, Canada (2016). www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce.