Understanding Pharma


Book Description




An Introduction to Clinical Pharmaceutics


Book Description

This textbook describes a variety of dosage forms and their clinical importance and use. The use and behaviour of dosage forms in different age groups and patient groups will also be considered along with recent developments such as personalised therapies and genomics. It contains relevant examples and clinical case studies.




Drug Information


Book Description

Extensive coverage of the Internet as a source of and distribution means for drug information, and detailed sections on evaluating medical literature from clinical trials Audience includes Pharmacists, Pharmacy students and Pharmacy schools Updated to include using PDAs for medication information Covers the ethical and legal aspects of drug information management Nothing else like it on the market




Measuring Elemental Impurities in Pharmaceuticals


Book Description

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters , , and , together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials. It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters and and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter , including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.




A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition


Book Description

FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.




The Essential Guide to Pharmacy Residency Research


Book Description

The Essential Guide to Pharmacy Residency Research provides pharmacy students, residents, and practitioners with an accessible and practical overview of how to conduct research, empowering them with the self-assurance necessary to initiate and navigate a research project. After reading this book, one will understand that it is entirely possible to complete a high-quality research project within the timeframe allotted during a 1-year residency. Written by Yardlee S. Kauffman, PharmD, MPH, BCACP, CPH and Daniel M. Witt, PharmD, FCCP, BCPS, this book is designed to walk readers through the natural progression of a research project and can be especially helpful for those who don’t know where to begin. Along with expert advice from the authors, former pharmacy residents offer first-hand anecdotes that describe their early research experiences.




The Pharmacist Guide to Implementing Pharmaceutical Care


Book Description

Through the contributions of global experts, this book meets the growing need to understand the implementation and development of pharmaceutical care. Pharmaceutical Care Implementation details the clinical pharmacist's role in providing care to different kind of patients using clinical strategies that improve humanistic, economic and clinical outcomes. Written with a focus for students and pharmacists, this book offers multiple scenarios that serve to improve technical skills. These examples show step-by-step implementation processes from pharmacists who have worked for many years in these fields: drug-related problems, pharmaceutical care in different settings (community, hospital, home care), research outcomes, communication skills, indicators, advertising, remuneration of practice, standards, guidelines, protocols and teaching approaches for universities. Readers will use this book to:- Improve their skills to prevent, detect and solve drug-related problems - Understand the characteristics of care for patients in different settings- Consolidate knowledge from different global research outcomes- Develop and improve communication skills to establish relationships with patients and healthcare professionals.- Learn to use indicators, standards,guidelines,and protocols to guide and evaluate pharmaceutical care performance- Use different tools to advertise pharmaceutical care services- Document pharmaceutical care practices and create evidence for remuneration




A Practical Guide to Drug Development in Academia


Book Description

"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."







Pharmaceutical Production


Book Description

This title is a general introduction aimed at all those involved in the engineering stages required for the manufacturr of the active ingredient and its dosage forms.