Practical Pharmaceutics: An International Guideline for the Preparation, Care and Use of Medicinal Products

《實用藥劑學》包含了有關藥物的製備、品質控制、物流、配藥及使用的基本知識。書中有多位在歐洲醫院、學術界及產業工作的經驗豐富的藥劑師和科學家撰寫的章節，並提供實際範例以及有關當前良好製造規範（GMP）和基於GMP的指導方針及歐盟法規的資訊。在第二版中，所有章節均已更新，並加入了許多新的以及經過教學修訂的插圖和表格。此外，還新增了一章關於治療性蛋白質和先進療法藥品的內容。

從處方到生產，從使用說明到採購，以及藥物對環境的影響，本書提供了逐步的內容，幫助廣泛的讀者，包括學生和專業人士。它為所有直接與患者接觸的藥劑師提供產品知識，使他們能夠提供所需的藥物，妥善儲存藥物，必要時調整藥物，並向患者及照護者提供有關產品護理及如何維持產品品質的適當資訊。本書中所呈現的基本知識對於工業藥劑師也將非常有價值，幫助他們回顧並專注於所製造藥物的應用。

有關藥物設計、製備及品質管理的基本和實用知識，藥劑師可直接應用於社區和醫院藥局及產業中的生產工作。大學本科及研究生藥學學生將會發現書中所呈現的知識條理清晰，並有相關範例充分支持。

《實用藥劑學》已成為獲得藥物技術知識的可靠和公認來源。該書被多所國際大學和藥學院的課程所使用。

Paul Le Brun, PharmD, PhD, is hospital pharmacist and clinical pharmacologist of the Department of Clinical Pharmacy and Toxicology of Leiden University Medical Center, The Netherlands since 2017. He also teaches pharmacy students in quality, preparation and innovative medicines as associate professor at the university of Leiden.

Paul obtained his degree in pharmacy from the Groningen University in 1982. He started his career at the Dutch Laboratory of Pharmacists (LNA), department of the Royal Dutch Association of Pharmacists (KNMP). From 1985 until 1988 he was trained and worked as a hospital pharmacist in the Central Hospital Pharmacy of The Hague. He joined Merck Sharp&Dohme as production pharmacist from 1989 to 1992. From 1992 until 2017 he was director of production of the Central Hospital Pharmacy in The Hague combined with clinical tasks in Haga teaching hospital.

In 2001 he obtained his PhD: "Optimization of antibiotic inhalation therapy in Cystic Fibrosis.Studies on nebulized tobramycin. Development of a colistin dry powder inhaler system. The research was valued in 2000 with the KNMP Innovation Award. To date, his main research themes are Aseptic preparation and Medicinal product development.

Paul published numerous scientific papers and was author/editor of the first edition of Practical Pharmaceutics.Sylvie Crauste-Manciet obtained her degree in Pharmacy (PharmD) in 1993, her PhD in 1997 and accreditation to supervise research (HDR) in 2013 from the University of Paris Descartes, France. Until 1999, she combines hospital pharmacy and academic activities as specialist in pharmaceutical technologies for preparation of sterile and not sterile drugs for hospitalized patients e.g. cytotoxic drugs, parenteral nutrition, paediatric capsules in Paris, Bordeaux and she recently moved to Angers. As professor of pharmaceutical technologies, she developed specific research in nanosytems design and characterization firstly at UPCGI Laboratory, UMR 8151 CNRS- U1022 INSERM at Paris Descartes University then at ARNA, ChemBioPharm team, INSERM U1212 UMR 5320 CNRS at Bordeaux University and since September 2022 at MINT laboratory UMR INSERM 1066 /CNRS 6021 at Angers University. She created in 2016 a master's program dedicated for research on hospital pharmaceutical technology. Since 1998, she is the president of the European society of Hospital Pharmaceutical Technology (GERPAC) which is an association of European hospital pharmacists involved in the research and development of hospital preparations.

Sylvie Crauste-Manciet obtained her degree in Pharmacy (PharmD) in 1993, her PhD in 1997 and accreditation to supervise research (HDR) in 2013 from the University of Paris Descartes, France. Until 1999, she combines hospital pharmacy and academic activities as specialist in pharmaceutical technologies for preparation of sterile and not sterile drugs for hospitalized patients e.g. cytotoxic drugs, parenteral nutrition, paediatric capsules in Paris, Bordeaux and she recently moved to Angers. As professor of pharmaceutical technologies, she developed specific research in nanosytems design and characterization firstly at UPCGI Laboratory, UMR 8151 CNRS- U1022 INSERM at Paris Descartes University then at ARNA, ChemBioPharm team, INSERM U1212 UMR 5320 CNRS at Bordeaux University and since September 2022 at MINT laboratory UMR INSERM 1066 /CNRS 6021 at Angers University. She created in 2016 a master's program dedicated for research on hospital pharmaceutical technology. Since 1998, she is the president of the European society of Hospital Pharmaceutical Technology (GERPAC) which is an association of European hospital pharmacists involved in the research and development of hospital preparations.

Irene Krämer, PharmD, PhD, is Director of the Pharmacy Department of the University Medical Center at the Johannes Gutenberg-University Mainz (Germany) and Professor of Clinical Pharmacy at the faculty of pharmacy at the same university.

She obtained her doctorate in pharmaceutical chemistry and continued her postgraduate education at the Pharmacy Department of the Johannes Gutenberg-University and went on to complete her postdoctoral thesis in Pharmaceutical Technology, entitled Development, Quality Assurance, and Optimization of Ready-to-Use Parenteral Solutions in the Integrated Cancer Care Concept.

The research projects of Prof. Kraemer focus on experimental studies of the physicochemical and microbiological stability of ready-to-administer parenteral preparations mainly used in oncology and intensive care patients. Other research projects deal with the development and evaluation of clinical pharmacy services and the improvement of medication safety by digitalization and automation of the medication process. She also performed numerous studies regarding medication adherence of special patient groups.

Prof. Krämer published numerous scientific papers and isauthor/editor of several clinical pharmacy and pharmaceutical technology textbooks. She received the German Federal Cross of Merit for her dedication to hospital pharmacy and patient care.

Julian Smith is a registered pharmacist, and a Qualified Person (QP) responsible for assuring the quality of medicines. He has been a hospital pharmacist for much of his professional career. His time in hospital was spent in "technical services", mainly in Quality Assurance, where he was involved in the manufacture of Pharmaceutical "Specials" in licensed Production Units. His final role in the NHS was as the All-Wales Quality Assurance Pharmacist. During his career he has taken brief detours into both community pharmacy and academia. He was a lecturer in Pharmaceutics at Aston University in the UK. His PhD is in transdermal drug delivery, and this was where he developed a passion for formulation development which has driven his career. He became a director at Viridian Pharma where he wasinvolved in developing and applying for licensed pharmaceutical products. He is now a Director of JCS Pharma Consulting where he provides advice on product development, lectures in Quality Assurance, and acts as a contract Qualified Person.

Dr. H.J. (Herman) Woerdenbag is associate professor of pharmaceutical product care at the University of Groningen, Department of Pharmaceutical Technology and Biopharmacy. He is responsible for teaching activities (theory and practical) in pharmaceutical compounding and dispensing (small and medium scale, including quality management) and product care in the Pharmacy curriculum (BSc and MSc). He is teacher, coordinator and innovator of various compulsory and elective courses. He contributes to quality assurance in pharmacy education and curriculum renewal. Current research is mainly practice-oriented, in collaboration with (hospital) pharmacists in the Netherlands, and often linked with pharmacy education in galenics and compounding. His scientific and societal work covers publications on medicinal plants and herbal medicine, pharmaceutics and pharmaceutical product care.

保羅·勒布倫（Paul Le Brun），藥學博士（PharmD）、哲學博士（PhD），自2017年以來擔任荷蘭萊頓大學醫學中心臨床藥學與毒理學系的醫院藥師及臨床藥理學家。他同時擔任萊頓大學的副教授，教授藥學學生有關品質、製備及創新藥物的課程。

保羅於1982年獲得格羅寧根大學的藥學學位。他的職業生涯始於荷蘭藥師實驗室（LNA），該機構隸屬於荷蘭皇家藥師協會（KNMP）。從1985年至1988年，他在海牙的中央醫院藥房接受培訓並擔任醫院藥師。1989年至1992年，他在默克·沙普與多美（Merck Sharp&Dohme）擔任生產藥師。從1992年至2017年，他擔任海牙中央醫院藥房的生產主任，並兼任哈加教學醫院的臨床任務。

在2001年，他獲得博士學位，研究題目為「囊性纖維化中抗生素吸入療法的優化：霧化托布霉素的研究，及一種多黏菌素乾粉吸入器系統的開發」。該研究於2000年獲得KNMP創新獎。至今，他的主要研究主題為無菌製備及藥品開發。

保羅發表了多篇科學論文，並擔任《實用藥學》第一版的作者及編輯。西爾維·克勞斯特-曼西耶（Sylvie Crauste-Manciet）於1993年獲得藥學學位（PharmD），1997年獲得博士學位，並於2013年獲得巴黎笛卡爾大學的研究指導資格（HDR）。直到1999年，她結合醫院藥學與學術活動，專注於為住院病人準備無菌及非無菌藥物的藥學技術，例如細胞毒性藥物、靜脈營養及兒科膠囊，曾在巴黎、波爾多工作，最近移居到昂熱。作為藥學技術教授，她在巴黎笛卡爾大學的UPCGI實驗室、波爾多大學的ARNA ChemBioPharm團隊及自2022年9月起在昂熱大學的MINT實驗室開展了針對奈米系統設計與特徵化的專門研究。她於2016年創立了一個專注於醫院藥學技術研究的碩士課程。自1998年以來，她擔任歐洲醫院藥學技術學會（GERPAC）的會長，該學會是由參與醫院製劑研究與開發的歐洲醫院藥師組成的協會。

伊琳·克雷默（Irene Krämer），藥學博士（PharmD）、哲學博士（PhD），是美因茨約翰·古騰堡大學醫學中心藥學部的主任，並擔任藥學院的臨床藥學教授。