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.Download Full Software
Biopharmaceutical Process Validation
A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, Download
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 physicochemicalDownload
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.Download
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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