Page 128 - Buletin JSKM 2021

127

ubatan kerana keseluruhan proses kelulusan sesuatu ubat melalui fasa serta prosedur operasi
standard yang ketat selain diaudit oleh badan regulatori yang pakar dalam bidang tersebut.

Rujukan

Center for Drug Evaluation and Research (CDER) (2001). Guidance for Industry: Statistical
Approaches to Establishing Bioequivalence. Diakses pada 28 Mac 2019.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-
approaches-establishing-bioequivalence

Cheah, K.Y., Mah, K.Y., Pang, L.H. et al. A randomized single-dose, two-period crossover
bioequivalence study of two fixed-dose Paracetamol/Orphenadrine combination preparations
in healthy volunteers under fasted condition. BMC Pharmacol Toxicol 21, 45 (2020).
https://doi.org/10.1186/s40360-020-00416-3

Clinical Pharmacy Working Committee (Clinical Pharmacokinetics Subspecialty) Pharmacy
Practice & Development Division Ministry of Health Malaysia (2019). Clinical
nd
pharmacokinetics pharmacy handbook. 2 edition.
(https://www.pharmacy.gov.my/v2/sites/default/files/document-upload/clinical-
pharmacokinetics-pharmacy-handbook-ccph-2nd-edition-rev-2.0.pdf)

Doogue, M. P., & Polasek, T. M. (2013). The ABCD of clinical pharmacokinetics. Therapeutic
advances in drug safety, 4(1), 5–7. https://doi.org/10.1177/2042098612469335

Website electronic medicines compendium (emc) diakses pada 26 Ogos 2021
https://www.medicines.org.uk/emc/product/6482/smpc