20
References
Achmad, D., Hariady, Y., Isakh, B., & Abdurahman, M. (2013). Strategi Pemakaian Epoetin Alfa Dalam Mempertahankan Kadar Hemoglobin Pada Kemoterapi Ajuvan Berbasis Antrasiklin Karsinoma Payudara Operabel. Indonesian Journal of Cancer, 7(1), 66098. Retrieved from https://www.neliti.com/publications/66098/strategi-pemakaian-epoetin-alfa-dalam-
mempertahankan-kadar-hemoglobin-pada-kemot
Araya, S., Lovsin-Barle, E., & Glowienke, S. (2015). Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure. Regulatory Toxicology and Pharmacology, 73(2), 515–520. https://doi.org/10.1016/j.yrtph.2015.10.001 Bajaj, S., Sakhuja, N., & Singla, D. (2012). Stability Testing of Pharmaceutical Products. Journal of
Applied Pharmaceutical Science, 2012(03), 129–138. Retrieved from https://japsonline.com/admin/php/uploads/409_pdf.pdf
Blanco, V. S., González-Freire, L., Dávila-Pousa, M. C., & Crespo-Diz, C. (2018). pH determination as a quality standard for the elaboration of oral liquid compounding formula. Farmacia Hospitalaria: Organo Oficial de Expresion Cientifica de La Sociedad Espanola de Farmacia Hospitalaria, 42(6), 221–227. https://doi.org/10.7399/fh.10932
BPOM RI. (2018). Penerapan Pedoman Cara Pembuatan Obat yang Baik. Jakarta: Badan Pengawas Obat dan Makan Republik Indonesia
Brown, H., Mahler, H.-C., Mellman, J., Nieto, A., Wagner, D., Schaar, M., … Wuchner, K. (2016).
Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry. PDA Journal of Pharmaceutical Science and Technology, 71(2), 147–162.
https://doi.org/10.5731/pdajpst.2016.006999
Dewi, D. R. N., Zakkia, L. U., Khoiruddin, W., & Harismah, K. (2018). Pengaruh pH Terhadap Lamanya Penyimpanan Sediaan Ekstrak Daun Seligi dan Eugenol dari Minyak Dan Cengkeh Sebagai Obat Antinyeri. Prosiding Seminar Sains Nasional Dan Teknologi, 1(1).
https://doi.org/10.36499/psnst.v1i1.2290
21
Dohou, A. M., Yémoa, A. L., Guidan, D. B. A., Ahouandjinou, S. H. S., Amoussa, A., Dossou, F. M., …
Dalleur, O. (2022). Assessment of the Quality of Injectable Antibiotics in Benin. The American Journal of Tropical Medicine and Hygiene, 107(1), 24–31. https://doi.org/10.4269/ajtmh.21- 0844
Du, C., Xu, J., Song, H., Tao, L., Lewandowski, A., Ghose, S., … Li, Z. J. (2019). Mechanisms of color
formation in drug substance and mitigation strategies for the manufacture and storage of therapeutic proteins produced using mammalian cell culture. Process Biochemistry, 86, 127–
135. https://doi.org/10.1016/j.procbio.2019.08.013
EDQM. (2022). Technical guide for the elaboration of monographs. 8th edition. Retrieved from https://www.edqm.eu/documents/52006/66555/02-technical-guide-elaboration-
monographs-8th-edition-2022.pdf/46b07f46-779d-687d-1455- 74d8a9a515ee?t=1656321894803
Gilleskie, G., Rutter, C., & McCuen, B. (2021). Biopharmaceutical Manufacturing. In De Gruyter eBooks.
https://doi.org/10.1515/9783110616880
Golay, J., Semenzato, G., Rambaldi, A., Foà, R., Gaidano, G., Gamba, E., … Regazzi, M. (2013). Lessons
for the clinic from rituximab pharmacokinetics and pharmacodynamics. MAbs, 5(6), 826–837.
https://doi.org/10.4161/mabs.26008
Goyal, P., & Gupta, V. (2021). Building Quality in Pharmaceutical Products. Retrieved from https://www.researchgate.net/profile/Prateek-Goyal-
2/publication/357621620_Building_Quality_in_Pharmaceutical_Products/links/61d6ab29b83 05f7c4b2641b3/Building-Quality-in-Pharmaceutical-Products.pdf
Kasar, S., Jadhav, A., Kadam, S., & Patil, A. (2022). QA/QC in Pharmaceutical Science: A Review.
International Journal of Pharmaceutical Research and Applications, 7, 310.
https://doi.org/10.35629/7781-0701310314
Kesik‐Brodacka, M. (2017). Progress in biopharmaceutical development. Biotechnology and Applied Biochemistry, 65(3), 306–322. https://doi.org/10.1002/bab.1617
22
KGM. (n.d.). Kalbio Global Medika. Retrieved October 3, 2023, from kalbio.co.id website:
https://kalbio.co.id
Kitchener, B. G., Wainwright, J., & Parsons, A. J. (2017). A review of the principles of turbidity measurement. Progress in Physical Geography: Earth and Environment, 41(5), 620–642.
https://doi.org/10.1177/0309133317726540
Larkins, M. C., & Thombare, A. (2023). Osmometer. Retrieved from PubMed website:
https://www.ncbi.nlm.nih.gov/books/NBK589659/
Lorefice, S., Romeo, R., Santiano, M., & Capelli, A. (2014). Original pycnometers for volatile liquid density over wide ranges of temperature and pressure: practical example. Metrologia, 51(3), 154–160. https://doi.org/10.1088/0026-1394/51/3/154
Moghimi, N., & Park, S. (2017). Leakage assessment of flexible pouches using dye penetration test with correlation to modeled bacterial aerosol challenge test. Food Science and Biotechnology, 26(4), 947–953. https://doi.org/10.1007/s10068-017-0134-y
Pack, B. W., Montgomery, L. L., & Hetrick, E. M. (2015). Modernization of Physical Appearance and Solution Color Tests Using Quantitative Tristimulus Colorimetry: Advantages, Harmonization, and Validation Strategies. Journal of Pharmaceutical Sciences, 104(10), 3299–3313.
https://doi.org/10.1002/jps.24565
Peláez, S. S., Mahler, H.-C., Herdlitschka, C., Wertli, T., Kahl, M., Koulov, A., … Mathaes, R. (2019).
Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies. PDA Journal of Pharmaceutical Science and Technology, 73(3), 220–234.
https://doi.org/10.5731/pdajpst.2018.009332
Rajan, P., Sindhuja, P., Nagabhushanam, M., Bonthagarala, B., Reddy, D., & Ramakrishna, G. (2018). A Review on in Process and Finished Products Quality Control Tests for Tablets According to Pharmacopoeias. World Journal of Pharmacy and Pharmaceutical Sciences SJIF Impact Factor, 7(9), 305–315. https://doi.org/10.20959/wjpps20189-12199
23
Rao, G., & Goyal, A. (2016). Development of stability indicating studies for pharmaceutical products:
an innovative step. International Journal of Pharmaceutical Chemistry and Analysis, 3(3), 110.
https://doi.org/10.5958/2394-2797.2016.00017.4
Rosdiana, D. (2017). Penggunaan Insulin Basal dalam Praktek Sehari-hari: Panduan Praktis untuk Dokter Umum. Jurnal Ilmu Kedokteran, 8(2), 53. https://doi.org/10.26891/jik.v8i2.2014.53-57 Ruesch, M. N., Benetti, L., Berkay, E., Cirelli, D. J., Frantz, N., Gastens, M. H., … Stults, J. (2021).
Strategies for Setting Patient-Centric Commercial Specifications for Biotherapeutic Products.
Journal of Pharmaceutical Sciences, 110(2), 771–784.
https://doi.org/10.1016/j.xphs.2020.09.048
Savjani, K. T., Gajjar, A. K., & Savjani, J. K. (2012). Drug solubility: Importance and enhancement techniques. ISRN Pharmaceutics, 2012, 1–10. https://doi.org/10.5402/2012/195727
Schmelzer, B., & Sutter, M. (2023). Tolerance Interval Approach for the Determination of Overfill of Liquid Parenteral Drug Products. PDA Journal of Pharmaceutical Science and Technology, 77(3), 181–196. https://doi.org/10.5731/pdajpst.2022.012743
Silva, M. H., Hudson, S. P., Tajber, L., Garin, M., Dong, W., Khamiakova, T., & Holm, R. (2022). Osmolality of Excipients for Parenteral Formulation Measured by Freezing Point Depression and Vapor Pressure – A Comparative Analysis. Pharmaceutical Research.
https://doi.org/10.1007/s11095-022-03262-6
Tani, J., Ito, Y., Satoshi Tatemichi, Makoto Yamakami, Fukui, T., Hatano, Y., … Tohru Hirato. (2020).
Physicochemical and biological evaluation of JR-131 as a biosimilar to a long-acting erythropoiesis-stimulating agent darbepoetin alfa. PLOS ONE, 15(4), e0231830–e0231830.
https://doi.org/10.1371/journal.pone.0231830
Usach, I., Martinez, R., Festini, T., & Peris, J.-E. (2019). Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Advances in Therapy, 36(11), 2986–2996. https://doi.org/10.1007/s12325-019-01101-6
24
Utomo, A., Widyati, W., & Susilo, D. H. (2020). Efektivitas Profilaksis Primer Filgrastim Pada Pasien Kanker Payudara terhadap Insiden Neutropenia. MPI (Media Pharmaceutica Indonesiana), 3(1), 52–59. https://doi.org/10.24123/mpi.v3i1.2831
Vigneron, J., Matthieu Sacrez, D’Huart, E., & Béatrice Demoré. (2023). Assessment of the relevance of
osmolality measurement as a criterion for the stability of solutions. Pharmaceutical Technology in Hospital Pharmacy, 8(1). https://doi.org/10.1515/pthp-2022-0008
Wang, W. (2015). Tolerability of hypertonic injectables. International Journal of Pharmaceutics, 490(1), 308–315. https://doi.org/10.1016/j.ijpharm.2015.05.069
Yuwono, M. A. B., & Widyastuti, R. (2016, April 13). Implementasi Metode Suggestion System (Ss) Pada Pengujian Bakteri Patogen Sampel Bahan Baku Di Laboratorium Mikrobiologi Quality Control.
Retrieved September 14, 2023, from Semantic Scholar website:
https://www.semanticscholar.org/paper/Implementasi-Metode-Suggestion-System-(Ss)- Pada-Di-Yuwono-Widyastuti/c8fdbdd7e0fbe7473c83869c53c763ca81571c40