台灣大學藥學專業學院

Publications

Regulatory framework and product evaluation

Cheng CA, Jiang AL, Liu YR, Chang LC. Investigation of immunogenicity assessment of biosimilar monoclonal antibodies in the United States. Clin Pharmacol Ther. 2023 Aug 27. doi: 10.1002/cpt.3033. Epub ahead of print. PMID: 37634125.
Liu YH, Chen YS, Tseng T, Jiang ML, Gau CS, Chang LC. Regulatory considerations for generic products of non-biological complex drugs. J Food Drug Anal. 2023;31:20-31. doi: 10.38212/2224-6614.3441.
Huang YJ, Chao WY, Wang CC, Chang LC. Orphan drug development: The impact of regulatory and reimbursement frameworks. Drug Discov Today 2022;27:1724-32.
doi: 10.1016/j.drudis.2022.03.002.
Hsiang NC, Huang WF, Gau CS, Tsai TW, Chang LC. The impact of The Rare Disease and Orphan Drug Act in Taiwan. J Food Drug Anal 2021;29:717-25. doi: 10.38212/2224-6614.3383.
Liou JS, Chang LC. Investigation of quality review issues and the association with application characteristics for new drug applications in first-cycle reviews. Regul Toxicol Pharmacol 2019;108:104448. doi: 10.1016/j.yrtph.2019.104448.
Chang LC. The biosimilar pathway in the USA: an analysis of the innovator company and biosimilar company perspectives and beyond. J Food Drug Anal 2019;27:671-8. doi: 10.1016/j.jfda.2019.03.003.
Breder CD, VanHeusen M, Chang LC. Correlates of time to approval and other clinical development periods. Drug Discov Today 2019;24:1871-6. doi: 10.1016/j.drudis.2019.05.027.
Chang LC, Vanheusen M, Fang X, Breder CD. Identification of factors associated with first-cycle drug approval rates and regulatory outcomes for new drug applications. Pharmacol Res 2019;139:166-72. doi: 10.1016/j.phrs.2018.11.004.
Chang LC, Colonna TE. Recent updates and challenges on the regulation of precision medicine: The United States in perspective. Regul Toxicol Pharmacol 2018;96:41-7. doi: 10.1016/j.yrtph.2018.04.021.
Chang LC, Mahmood R, Qureshi S, Breder CD. Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications. PLoS One 2017;12:e0178104. doi: 10.1371/journal.pone.0178104.
Chang LC, Kang JJ, Gau CS. Development of the risk-based, phased-in approach for the international harmonization of the regulation of container closure systems for drugs in Taiwan. Regul Toxicol Pharmacol 2016;77:252-6. doi: 10.1016/j.yrtph.2016.03.018.
Chang LC, Kang JJ, Gau CS. The evolution and challenges for the international harmonization of the regulation of pharmaceutical excipients in Taiwan. Regul Toxicol Pharmacol 2015;73:947-52. doi: 10.1016/j.yrtph.2015.09.020.
Chang LC, Gau CS. Statistics, quality review issues, and beyond for generic drug applications in Taiwan. Ther Innov Regul Sci 2013;47:670-7. doi: 10.1177/2168479013495687.

Real-world evidence and health care utilization

Wu CC, Tsai SL, Ku PJ, et al. Cost-benefit of reimbursement for pharmaceutical care in Taiwan. J Am Coll Clin Pharm 2021 Feb 3. doi: 10.1002/jac5.1404.
Hsu CY, Chen WJ, Chen HM, Tsai HY, Hsiao FY. Impact of changing reimbursement criteria on statin treatment patterns among patients with atherosclerotic cardiovascular disease or cardiovascular risk factors. J Clin Pharm Ther 2020 Nov 12. doi: 10.1111/jcpt.13299.
Liao KH, Ko BS, Chen LK, Hsiao FY. Factors affecting usage levels and trends of innovative oncology drugs upon and after reimbursement under Taiwan National Health Insurance: interrupted time series analysis. Clin Transl Sci 2020;13:1288-97. doi: 10.1111/cts.12829.
Chen WW, Lin CW, Huang WI, Chao PH, Gau CS, Hsiao FY. Using real-world evidence for pharmacovigilance and drug safety-related decision making by a resource-limited health authority: 10 years of experience in Taiwan. Pharmacoepidemiol Drug Saf 2020;29:1402-13. doi: 10.1002/pds.5084.
Wang CY, Fu SH, Hung CC, Yang RS, Lin JW, Chen HM, Hsiao FY, Shen LJ. Impact of the requirement of bone mineral density evidence on utilization of anti-osteoporosis medications, clinical outcome and medical expenditures of patient with hip fracture in Taiwan. Int J Health Policy Manag 2020 Oct 3. doi: 10.34172/ijhpm.2020.169.
Huang SY, Chen HM, Liao KH, Ko BS, Hsiao FY. Economic burden of cancers in Taiwan: a direct and indirect cost estimate for 2007-2017. BMJ Open 2020;10:e036341. doi: 10.1136/bmjopen-2019-036341.
Shih YR, Liao KH, Chen YH, Lin FJ, Hsiao FY. Reimbursement lag of new drugs under Taiwan’s National Health Insurance System compared with United Kingdom, Canada, Australia, Japan, and South Korea. Clin Transl Sci 2020;13:916-22. doi: 10.1111/cts.12778.
Peng LN, Chen LJ, Lu WH, Tsai SL, Chen LK, Hsiao FY. Post-acute care regains quality of life among middle-aged and older stroke patients in Taiwan. Arch Gerontol Geriatr 2019;83:271-76. doi: 10.1016/j.archger.2019.04.011.
Lin CW, Huang WI, Chao PH, Chen WW, Hsiao FY. Temporal trends and patterns in carbamazepine use, related severe cutaneous adverse reactions, and HLA-B*15:02 screening: a nationwide study. Epilepsia 2018;59:2325-39. doi: 10.1111/epi.14599.
Peng LN, Lu WH, Liang CK, Chou MY, Chung CP, Tsai SL, Chen ZJ, Hsiao FY, Chen LK, and the Taiwan Stroke Postacute Care (PAC) Study Group. Functional outcomes, subsequent healthcare utilization, and mortality of stroke postacute care patients in Taiwan: a nationwide propensity score-matched study. J Am Med Dir Assoc 2017;18:990.e7-12. doi: 10.1016/j.jamda.2017.06.020.
Chen CC, Hsiao FY, Shen LJ, Wu CC. The cost-saving effect and prevention of medication errors by clinical pharmacist intervention in a nephrology unit. Medicine (Baltimore) 2017;96:e7883. doi: 10.1097/MD.0000000000007883.
Lin CW, Wang CH, Huang WI, Ke WM, Chao PH, Chen WW, Hsiao FY. Impact of safety-related regulations on codeine use in children: a quasi-experimental study using Taiwan’s National Health Insurance Research Database. Drug Saf 2017;40:615-27. doi: 10.1007/s40264-017-0524-3.
Wen TJ, Wen YW, Chien CR, Chiang SC, Hsu WY, Shen LJ, Hsiao FY. Cost-effectiveness of granulocyte colony-stimulating factor prophylaxis in chemotherapy-induced febrile neutropenia among breast cancer and non-Hodgkin’s lymphoma patients under Taiwan’s National Health Insurance System. J Eval Clin Pract 2017;23:288-93. doi: 10.1111/jep.12597.
Chen HL, Shen LJ, Wei CP, Lu HM, Hsiao FY. Decision to adopt medical technology under the National Health Insurance System in Taiwan: case study of new molecular targeted drugs among non-small cell lung cancer patients. J Eval Clin Pract 2015;21:808-16. doi: 10.1111/jep.12382.