Hasil Pencarian  ::  Simpan CSV :: Kembali

"The pharmaceutical industry is praised as a leader in high technology innovation and the creator of products that increase both longevity and quality of life for people throughout the world. Yet the industry is also reviled for its marketing and pricing practices and even its research and development priorities. This book uses the tools of economic analysis to explore the conflicting priorities and aims of the pharmaceutical industry, from both an American and worldwide perspective. This second edition includes six new chapters on emerging topics such as the broadened role of FDA regulations, alternative drugs or "nutraceuticals," and biotechnology and other industries related to pharmaceuticals. Existing chapters are fully revised and updated to include new materials. The introduction is also updated to address the volatile pace of pharmaceutical innovation and how the pharmaceutical industry has responded to the emergence of managed care. "

"This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries."

"Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort. Presents a comprehensive view of the field of quality assuranceAn approach grounded in direct experienceUses diagrams and figures to clarify analytical points."

"The aim of this research is to provide a theoretical framework for strategic alliance behavior by firms that seek to sustain a competitive advantage The objective is to integrate the transaction cost economic explanations, strategic behavior of the firm, in investigating strategic alliance phenomena in relation to competitive positioning. The fundamental premise of this research is that inter-firm relationships are embedded within the alliance, The hyphoteses are tested by applying quantitative analysis to data collected on 108 alliances that are involved in the development of pharmaceutical companies in Asia. A full survey was mailed to executives or key individual involved in the implementation of the alliances. The results of this research confirm our framework and also indicates that when firms build relational: capital in conjunction with an integrative approach to managing conflict they are able to achieve both organizational learning and protecting core assets simultaneously, Relational capital based on mutual trust and interaction between alliance partners creates a basis for learning and know-how transfer across accross the exchange the lekage of critical know how between them. Furthermore research indicates that through learning and acquining new importang information as well as some critical capability or skill from the partner while at the same time,m being able to protect its core capabilities and its crown jewels the company will compete effectively in the market. The research makes an important contribution to the literature by determining whether strategic alliances sustain competitiveness for firms pursuing a cooperative strategy."

"Menteri Kesehatan memberikan izin kepada industri farmasi untuk melakukan kegiatan pembuatan obat atau bahan obat dan memiliki peran yang esensial dalam ketersediaan obat-obatan yang memenuhi standar, aman, bermutu, dan bermanfaat. Pada proses pembuatan obat, setiap industri farmasi harus menerapkan Cara Pembuatan Obat yang Baik (CPOB) yang bertujuan untuk menjamin obat dibuat secara konsisten, memenuhi persyaratan yang ditetapkan dan sesuai dengan tujuan penggunaannya.

---

The Minister of Health grants permission to the pharmaceutical industry to carry out activities for the manufacture of drugs or medicinal ingredients and has an essential role in the availability of medicines that meet standards, are safe, quality and useful. In the process of making drugs, each pharmaceutical industry must implement a Good Drug Manufacturing Method (GMP) which aims to ensure that the drug is made consistently, meets the requirements set and in accordance with the intended use."

"Studi ini bertujuan menganalisis dampak COVID-19 terhadap perdagangan (ekspor dan impor) pada industri farmasi di negara anggota ASEAN. Dengan menggunakan metode Pseudo Poisson Maximum Likelihood (PPML) serta data jumlah kasus kumulatif COVID-19 dan data nilai ekspor dan impor industri farmasi selama periode Januari 2019 sampai Desember 2020, hasil estimasi menunjukkan bahwa jumlah kasus terinfeksi pada negara anggota ASEAN tidak berpengaruh terhadap nilai ekspor produk farmasi negara anggota ASEAN. Adapun di sisi impor, jumlah kasus terinfeksi COVID19 kumulatif pada negara ASEAN berdampak secara positif signifikan terhadap nilai impor produk farmasi negara anggota ASEAN.

---

This study aims to analysis the impact of COVID-19 on trade (exports and imports) in the pharmaceutical industry in ASEAN member countries. By using the Pseudo Poisson Maximum Likelihood (PPML) method as well as data on the cumulative number of COVID-19 cases and data on exports and imports of the pharmaceutical industry during the period January 2019 to December 2020, the estimation results show that the number of infected cases in ASEAN member countries has no effect on export value. pharmaceutical products of ASEAN member countries. On the import side, the number of cumulative COVID-19 infected cases in ASEAN countries has a significant positive impact on the import value of pharmaceutical products from ASEAN member countries."

"Produk steril merupakan produk yang bebas dari mikroba, partikel, dan pirogen sehingga dalam pembuatannya alat dan bahan yang digunakan harus terjamin sterilitas dan kebersihannya. Oleh karena itu, vial yang digunakan untuk pengemasan produk steril harus dicuci terlebih dahulu untuk menghilangkan pengotor yang ada didalamnya. Waktu pencucian vial 50R dengan vial washing machine Hydra 1000 6C di PT. CKD Otto Pharmaceutical memerlukan recycle water washing time, compressed air blowing time, dan washing time selama 9,0 detik. Lamanya waktu pencucian akan berdampak terhadap jumlah water for injection (WFI) dan listrik yang digunakan. Tujuan dibuat penelitian ini adalah untuk mempersingkat waktu pencucian vial 50R dengan cara menurunkan blowing time pencucian vial ukuran 50R dan penghematan biaya water for injection (WFI) yang digunakan setelah dilakukan penurunan blowing time. Metode yang digunakan untuk pengambilan data adalah dengan melakukan wawancara, studi literatur, dan pengambilan data primer. Hasil yang didapatkan adalah blowing time pencucian vial 50R menurun dari 9,0 detik mejadi 4,0 detik dengan konsumsi WFI dengan penurunan biaya water for injection (WFI) dari Rp 3.709.000 menjadi Rp 1.629.000.

---

Sterile products are products that are free from microbes, particles and pyrogens, so that in their manufacture the tools and materials used must be guaranteed to be sterile and clean. Therefore, vials used for packaging sterile products must be washed first to remove the impurities inside. Washing time for 50R vials with Hydra 1000 6C vial washing machine at PT. CKD Otto Pharmaceutical requires recycle water washing time, compressed air blowing time, and washing time of 9.0 seconds. The length of washing time will have an impact on the amount of water for injection (WFI) and electricity used. The aim of this research is to shorten the washing time for 50R vials by reducing the blowing time for washing 50R vials and saving the cost of water for injection (WFI) used after reducing the blowing time. The method used to collect data is by conducting interviews, literature studies, and collecting primary data. The results obtained were that the blowing time for washing 50R vials decreased from 9.0 seconds to 4.0 seconds with WFI consumption and reduced water for injection (WFI) costs from IDR 3,709,000 to IDR 1,629,000."