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"Pendahuluan: Docetaxel telah menunjukkan efek dalam pengobatan CRPC biladigunakan sebagai monoterapi atau dalam kombinasi dengan kemoterapi lainnya.Banyak penelitian telah menunjukkan korelasi penurunan Prostate Specific Antigen PSA dengan kesintasan pasien CRPC yang mendapatkan terapi Docetaxel. Penelitian-penelitian sebelumnya juga menyatakan adanya korelasi antara volumeprostat, Gleason Score, dan insiden metastasis dengan nilai PSA. Penelitian inibertujuan untuk menganalisis hubungan antara volume prostat, Gleason Score, danada tidaknya metastasis terhadap penurunan PSA sebagai prediktor respon padapasien CRPC yang mendapatkan Docetaxel. Metode: Penelitian analitik retrospektif dengan mengunakan data rekam medisRumah Sakit Umum H. Adam Malik Medan yang dilaksanakan pada periode 1Januari 2016-31 Juli 2016. Populasi dan sampel dalam penelitian ini adalah seluruhpasien dengan penderita CRPC yang telah menjalani kemoterapi Docetaxelsebanyak 10 siklus. Pasien yang memenuhi kriteria inklusi, dipaparkan denganvariabel independen Taksiran Besar Prostat, Skor Gleason, Status Metastase danvariabel dependen perubahan PSA. Hasil: Sebanyak 8 pasien yang memenuhi kriteria inklusi yang berusia rata-rata 65tahun dengan taksiran berat prostat 38,6 gram dengan skor gleason ≥ 7 sebanyak 6 orang 75 sedangkan.

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Introduction: Docetaxel has shown efficacy in CRPC treatment as monotherapy or combination therapy. Previous research showed a correlation between prostat volume, Gleason score, and metastases with PSA value. This study aimed toanalyze the correlation between prostat volume, gleason score, and metastases withPSA value decrement as a response predictor in CRPC patients who receiveDocetaxel.

Methods: This is a retrospective analytic research, using data in medical recordsin RSU H. Adam Malik Medan, conducted on January 1 July 31 2016. Populationand samples in this research are patients with CRPC who already received 10 cyclesof Docetaxel chemotherapy. Patients that fulfilled the inclusion criteria areanalyzed with dependent and independent variables estimated prostate volume,Gleason Score, and metastatic status.

Results: Total of 8 patients who fulfilled inclusion criteria were averagely 65 yearsold, estimated prostate weight of 38.6 gram, and 6 people had Gleason score ≥ 7 75 and 2 people had Gleason score "

"Human oral tongue cancer (SP-C1) is thought to be a high grade malignancy. Despite advances in surgery, radiotherapy, chemotherapy and combination therapy, prognosis and survival of patients with human tongue cancer have not significantly improved over the past several decades. Treatment options for recurrent or refractory tongue cancer are limited. Therefore, as a strategy for refractory cancer, anti-mitotic chemotherapy and its mechanisms are of considerable interest, including those using docetaxel hydrate for inducing maspin protein. In the current study, the mechanisms responsible for growth suppression and metastasis of SP-C1 by docetaxel hydrate through induction of maspin regulation were investigated. To evaluate in vitro cell proliferation and cell metastasis, MTT and out-growth assays were performed, respectively. Furthermore, the expression of maspin mediated by docetaxel hydrate was analysed by Western blotting. The results showed that treatment with 50 g/ml docetaxel hydrate significantly suppressed SP-C1 cell growth from day 1. Strong inhibition of metastasis of SP-C1 cells was also shown by treatment with 50 g/ml of docetaxel hydrate. Moreover, a significant induction of maspin regulation was detected in cells treated with 10 and 50 g/ml of docetaxel hydrate. However, the same protein level wasdemonstrated in -tubulin expression. These findings suggest thatdocetaxel hydrate may have potential for powerful anti-mitoticchemotherapy through induction of maspin regulation."

"Potensi kegagalan pada proses produksi dapat diatasi dengan mengidentifikasi dan menganalisis kesalahan akibat proses yang tidak kompeten sehingga menghambat kualitas produk. Laporan ini mengkaji penyebab hambatan dalam proses transfer produk Docetaxel dari tahap mixing ke filling di PT. Fonko International Pharmaceuticals. Hambatan pada proses transfer produk menyebabkan penurunan produktivitas, terutama terkait dengan penyumbatan filter akibat tingginya viskositas formulasi Docetaxel yang mengandung Polysorbate 80. Penelitian ini bertujuan untuk mengidentifikasi akar masalah penyumbatan filter, mengevaluasi tindakan perbaikan yang dilakukan, serta dampaknya terhadap produktivitas. Tindakan perbaikan proses yang diterapkan mencakup peningkatan suhu huber pada mixing tank dari 22,5°C menjadi 23,5°C dan penggunaan jacket heater pada Polysorbate 80 dengan suhu 40°C selama 15 menit. Hasil tindakan ini menunjukkan penurunan penyumbatan filter dan peningkatan produktivitas, meskipun beberapa batch masih mengalami masalah buffer tank low. Dari pengamatan, peningkatan suhu dan penggunaan jacket heater terbukti membantu, namun belum sepenuhnya menyelesaikan masalah. Selain itu, pemasok filter, Merck, merekomendasikan penggunaan filter Aervent-50 0,2 µm dengan peningkatan luas area filter, yakni 0,18 m² untuk batch 10 liter dan 0,70 m² untuk batch 60 liter, sebagai solusi jangka panjang untuk mengurangi penyumbatan yang lebih signifikan.

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The potential failures in the production process can be addressed by identifying and analyzing errors caused by incompetent processes that hinder product quality. This report examines the causes of bottlenecks in the transfer process of Docetaxel from the mixing to the filling stage at PT. Fonko International Pharmaceuticals. The bottlenecks in the product transfer process result in decreased productivity, primarily due to filter blockage caused by the high viscosity of the Docetaxel formulation containing Polysorbate 80. This study aims to identify the root cause of the filter blockage, evaluate the corrective actions taken, and assess their impact on productivity. The corrective actions implemented included increasing the huber temperature in the mixing tank from 22.5°C to 23.5°C and using a jacket heater on Polysorbate 80 at 40°C for 15 minutes. These actions showed a reduction in filter blockage and an increase in productivity, although some batches still experienced buffer tank low issues. Observations revealed that increasing the temperature and using the jacket heater helped, but did not completely resolve the problem. Additionally, the filter supplier, Merck, recommended using Aervent-50 0.2 µm filters with an increased filter surface area, specifically 0.18 m² for 10-liter batches and 0.70 m² for 60-liter batches, as a long-term solution to mitigate more significant blockages. "