Pharmaceutical Preformulation And Formulation, By Mark Gibson

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry. Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses: candidate drug selection drug discovery and development preformulation predictions and drug selections product design to commercial dosage form biopharmaceutical support in formulation development and more.

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, Second Edition

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry.

Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses:

candidate drug selection drug discovery and development preformulation predictions and drug selections product design to commercial dosage form biopharmaceutical support in formulation development and more.

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Basic Pharmacokinetics

This is the essential guide to the study of absorption, distribution, metabolism and elimination of drugs in the body. Pharmacokinetics and biopharmaceutics courses have been included in pharmacy curricula in the USA and Europe for several years. Pharmacokinetics is the study of absorption, distribution, metabolism and elimination of drugs in the body. Pharmacists must understand this to ensure appropriate drug regimen for patients. The scope and the intent of this textbook is to provide the reader with a basic intuitive understanding of the principles of pharmacokinetics and biopharmaceutics and how these principles, along with the equations presented in each chapter, can be applied to achieve successful drug therapy. The application of pharmacokinetics principles and equations are illustrated by providing the reader with data available in the literature. As pharmacokinetics is basically mathematical in nature, a chapter has been included to provide the reader with a basic review of the mathematical principles and graphing techniques necessary to understand pharmacokinetics. At the start of each chapter, important objectives are listed to accentuate and identify the key points of the chapter. When an important and clinically applicable equation appears in the text, a paragraph will follow explaining the significance and therapeutic applications of that equation. Additionally, this paragraph includes and explains relevant factors influencing parameters in an equation. When applicable, at the end of an important equation, a general profile illustrating the relationship between the two variables of an equation will be presented. This approach should make the subject matter much more accessible to the student. Each chapter concludes with related problem sets and problem solving exercises for the student to work through. This should enable the reader to become more adept at solving pharmacokinetic problems arising in drug therapy and understanding the applications and utility of equations in clinical pharmacokinetics and practice. As you can see from the contents, the book is organised into eighteen chapters, the first consists of mathematical principles necessary to understand pharmacokinetics and an overview of the subject matter. The remaining chapters are organised in an order which should be easy for the reader to follow. Clearance and other essential fundamental pharmacokinetic parameters are introduced early in the book as the student will need to apply these concepts in subsequent chapters. A uniform set of notation will be adopted throughout the textbook (a table of which will be at start of the book).

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Filtration in the Biopharmaceutical Industry

This timely resource offers comprehensive examinations of the most recent developments in the field, from prefiltration methods to final, gas, and tangential flow filtration techniques. Delineates filtration in a host of applications, including virus removal, protein binding, and sterility testing and introduces new, membrane-based technologies for the biopharmaceutical industry! Addressing quality, security, economic, process development, and regulatory topics, Filtration in the Biopharmaceutical Industry presents pre- and sterility grade filters, charge-modified filter media, and aids to filtration discusses filter quality assurance, pore size, extractables, and compatibilities in various filters examines filter design and construction analyzes integrity testing, test sensitivity, and automation furnishes novel filtration flow methods explains filter validation summarizes the U.S. Food and Drug Administration regulations governing filtration and more!

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Biopharmaceutics and Pharmaceutical Calculations Tutorials - Australian Pharmacy Examining Council

Two computer based educational modules were developed using the authoring package ToolBook Multimedia CBT Edition (Asymetrix Corporation), operating on a Windows® platform, and distributed on disk. They included tuition and assessment in the areas of pharmaceutical calculations (M1) and biopharmaceutics (M2) and were aimed at assisting overseas qualified pharmacists preparing for an Australian registration exam. Presented are the results of evaluations for the assessment programs' level of achievement of set educational objectives, frequency and patterns of use. Respondents (n=32) rated 'high-very high' the extent to which the following objectives were met: encouragement of testing of tutorial knowledge (M1: 90.3%; M2: 90.0%); provision of practice using the examination question format (M1: 90.0%; M2: 96.5%); encouragement of review of tutorials based on test performance (M1: 83.9%; M2: 86.7%). The analysis of data disks (n=58) on assessment program use indicated: total tests: (M1: 1,713; M2: 1,152); questions attempted: (M1: 20,900; M2: 15,921); timer option used: this was selected in 36.9% of total tests; period of testing with timer (118.4h) and without timer (598.1h) (maximum allowable question time recorded). Overall, the assessment programs were found very valuable components of each module. They were perceived to have met their set objectives and were significantly used.

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Biopharmaceutical Process Validation

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

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Developing Solid Oral Dosage Forms: Pharmaceutical Theory&Practice

This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:

Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms 

Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies 

New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development 

The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards 

It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter 

A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies.

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Development of Biopharmaceutical Parenteral Dosage Forms

This up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products;covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

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Encyclopedia of Biopharmaceutical Statistics, Second Edition

Millennium Pharmaceuticals, Cambridge, MA. Resource offers more than 3,300 lists expanded to reflect amendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development. Offers more than 3,000 equations, tables, and figures. Previous edition not cited.

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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required.
This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States.

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