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"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."

"Pengelolaan obat secara tidak langsung berkaitan dengan kualitas kesehatan masyarakat, khususnya pada produk rantai dingin farmasi yang cenderung sensitif terhadap perubahan selama proses penyimpanan dan pendistribusian. Sebagai fasilitas pelayanan kesehatan yang dekat dengan masyarakat, Apotek Roxy Cabang Sawangan harus memperhatikan proses pengelolaan tersebut. Oleh karena itu, diperlukan penelitian yang bertujuan untuk menganalisa implementasi sistem pengelolaan produk, data persentasi penjualan, serta peranan apoteker dalam penanganan produk rantai dingin farmasi di Apotek Roxy Cabang Sawangan. Penelitian dilakukan secara observasional melalui pendekatan kualitatif. Adapun observasi dilakukan melalui studi literatur berdasarkan referensi ilmiah, regulasi nasional, dan dokumen operasional di Apotek Roxy Cabang Sawangan. Selain itu dilakukan penarikan data penjualan produk rantai dingin farmasi selama satu tahun. Analisa data yang diperoleh dilakukan dengan melakukan wawancara lanjutan, pencatatan, dan pengamatan secara langsung. Penelitian menemukan bahwa pengelolaan produk rantai dingin farmasi di Apotek Roxy Cabang Sawangan telah sesuai dengan Cara Distribusi Obat yang Baik (CDOB). Selain itu, diketahui juga bahwa penjualan produk rantai dingin farmasi selama satu tahun didominasi oleh produk insulin. Apoteker memiliki tanggung jawab penuh untuk memastikan seluruh aspek pengelolaan obat di Apotek berjalan dengan benar.

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Drug management is indirectly related to the quality of public health, especially for pharmaceutical cold chain products, which tend to be sensitive to changes during the storage and distribution process. As the closest health service facility to the community, the Roxy Pharmacy Sawangan Branch must consider this management process. Therefore, research is needed to analyze the implementation of product management systems, sales percentage data, and the role of pharmacists in handling pharmaceutical cold chain products at the Roxy Pharmacy, Sawangan Branch.

The research was conducted observationally through a qualitative approach. Observations were made through literature studies based on scientific references, national regulations, and operational documents at the Roxy Pharmacy, Sawangan Branch. In addition, sales data for pharmaceutical cold chain products in the Roxy Pharmacy Sawangan Branch were collected for one year. Analysis of the data obtained was carried out by conducting follow-up interviews, recording, and direct observation. The study found that managing pharmaceutical cold chain products at the Roxy Pharmacy, Sawangan Branch followed Good Drug Distribution Methods (CDOB). In addition, the research found that insulin products dominate sales of pharmaceutical cold chain products for one year. Pharmacists are responsible for ensuring that all aspects of drug management in pharmacies run correctly."

"Contents: 1 Bond type and bond strength; 2 Hydrocarbons: alkanes, alkenes, aromatics and alkylhalides; 3 Amines; 4 Neutral and acidic nitrogen compounds; 5 Oxygen- and sulphur-containing functional groups; 6 Protein structure and its relevance to drug action; 7 DNA structure and its importance to drug action; 8 Drug absorption, distribution, metabolism and excretion; 9 Structure, activity and drug design; 10 Drugs affecting the adrenergic system; 11 Drugs exerting non-adrenergic effects on cardiac output and vascular tone; 12 Drugs interacting with mammalian enzymes; 13 Central nervous system depressants; 14 Analgesics; 15 Local anaesthetics; 16 Anti-cholinergic agents; 17 Anti-histamine drugs;18 CNS stimulants and CNS-active drugs affecting the serotonergic system; 19 Drugs affecting haemostasis and thrombosis; 20 Drugs affecting the endocrine system; 21 Anticancer drugs; 22 Antimicrobial chemotherapy: A. Antibiotics. B. Antituberculosis drugs; 23 Antiviral drugs; 24 Antifungal chemotherapy; 25 Antiparasitic drugs; 26 Vitamins and minerals; 27 Biotechnologically produced products; 28 Drug and gene delivery systems; 29 Alcohol"