FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics by Douglas J. Pisano, David Mantus.

14th October 2011
Tuesday 06:00 PM
Banaras

Hello friends,here is a vey good book that book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general prose style that makes it useful to both students and professionals.

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FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics by Douglas J. Pisano, David Mantus.

Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human drug and device development, research, manufacturing, and marketing. 

It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, easy to read prose style. It presents information drawn from a wide range of resources in a single, easy to use format. FDA approval can be a lengthy and expensive process. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase procedure must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance under FDA guidelines, this book demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval.

Microbiological Assay for Pharmaceutical Analysis A Rational Approach by William Hewitt

14th October 2011
Tuesday 05:35 PM
Banaras

Hi, friends its a very long gap that I have not interacted . Here is the book contains detailed evaluations of assays that illustrate typical experimental designs and addresses how to present a realistic assessment of the best potency estimate from a series of assays.

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Microbiological Assay for Pharmaceutical Analysis A Rational Approach by William Hewitt

A user-friendly guide for the evaluation of microbiological assays, Microbiological Assay for Pharmaceutical Analysis: A Rational Approach provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those sources of error. Beginning with a review of the theoretical basis for the quantitative aspects, the author discusses microbiological assay as a branch of pharmaceutical analysis and distinguishes it from biological assay in general. He draws attention to the microbiological aspects that may not be so obvious to the chemical analyst and to the analytical aspects that may not be so obvious to the microbiologist.

Drug Disposition and Pharmacokinetics: From Principles to Applications by Stephen H. Curry, Robin Whelpton

30th September 2011
Tuesday 10:35 PM
Banaras

Hi! this is an authoritative, comprehensive book on the fate of drug molecules in the body, including implications for pharmacological and clinical effects. The text provides a unique, balanced approach, examining the specific physical and biological factors affecting the absorption, distribution, metabolism and excretion of drugs, together with mathematical assessment of the concentrations in plasma and body fluids. Understanding the equations requires little more than a basic knowledge of algebra, laws of indices and logarithms, and very simple calculus. A companion web site contains additional illustrations, further equations and numerous worked examples.

Download Link:    http://www.fileserve.com/file/AVycScS/0470684461.rar

Drug Disposition and Pharmacokinetics: From Principles to Applications by Stephen H. Curry, Robin Whelpton

This book has its roots in the highly acclaimed book of the same name, written by Stephen Curry nearly thirty years ago, it is essentially a new book having been restructured and largely rewritten. This readable and informative book is an invaluable resource for professionals and students needing to develop a rational approach to the investigation and application of drugs.

Clinical Pharmacokinetics Concepts and Applications by Malcolm Rowland , Thomas Tozer

30th September 2011
Tuesday 10:19 PM
Banaras

Hello, since pharmacokinetics can greatly affect how different patients respond to the same drug, both students and physicians need a basic clinical understanding of this vital area. This textbook covers a tremendous range of topics important in pharmacokinetics and pharmacodynamics.

Download Link:    http://www.easy-share.com/1908354876.html

Clinical Pharmacokinetics Concepts and Applications by Malcolm Rowland , Thomas Tozer

The Third Edition of "Clinical Pharmacokinetics" provides a practical perspective, with these added features: considerations of both stereochemistry and the increasing number of polypeptide and protein drugs being developed; the range and number of problems at the end of each chapter has been expanded; a second color added to make the text more user friendly; and, important equations highlighted by shading.

This book is a very finely crafted comprehensive introduction to pharmacokinetics, with enough pharmacodynamics to give one context. If you are new to PK/PD and need to understand and work with the subject matter this is an excellent starting point and a fine reference. The prose is clear, the organization thoughtful, and the figures and diagrams are masterful - best in class. The authors are both renowned academics with extensive industrial experience. That background shines through in the thoughtful way that topics are motivated and explained. I found the questions useful and thought-provoking. Isn't it the case that the more iron one pumps in the gym, the stronger one is on the playing field?

Applied Clinical Pharmacokinetics by Larry A Bauer

30th September 2009
Tuesday 09:55 PM
Banaras

Hi friends written by a nationally recognized authority in pharmacokinetics, Applied Clinical Pharmacokinetics is full of essential topics for pharmaceutics, pharmacokinetics, therapeutics, and clinical pharmacy courses. It includes information that is critical for practitioners to learn and apply to patient care as well as extensive examples and problems with solutions so readers can master the outlined pharmacokinetic concepts.

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Applied Clinical Pharmacokinetics by Larry A Bauer

Putting pharmacokinetics into practice, this timely and comprehensive text delivers the latest procedures and data on today’s drugs and patient-specific dosing.

The best guide to pharmacokinetics for real-life pharmacy practice

Ideal for students, pharmacists, and other clinicians who want clear, useful, and up-to-date coverage of the latest standardized techniques and most recent pharmacokinetically monitored drugs

Essential topics for pharmaceutics, pharmacokinetics, therapeutics, and clinical pharmacy courses or can be used in a self-directed manner to self-teach or review important concepts and techniques

Inside: essential information on approaches to drug-dosing and monitoring in individual patients, including the latest data on serum concentrations, written by a nationally recognized leader in pharmacokinetics

Concepts in Clinical Pharmacokinetics by Joseph T. DiPiro, William J. Spruill, William E. Wade, Robert A. Blouin and Jane M. Pruemer

30th September 2009
Tuesday 09:47 PM
Banaras
Hi this is another book provides the basic pharmacokinetic concepts and procedures that are useful in pharmacy, medicine, and other healthcare professions. Topics include pharmacokinetics, half-life, elimination rate, AUC, two-compartment models, drug elimination process, vancomycin, and more.

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Concepts in Clinical Pharmacokinetics by Joseph T. DiPiro, William J. Spruill, William E. Wade, Robert A. Blouin and Jane M. Pruemer

This book is organized into 15 lessons. The first 11 lessons provide the basic pharmacokinetic concepts (absorption, distribution, elimination, pharmacodynamics, single- and multiple-dose administrations, protein binding, nonlinearity and model-independent methods), while the last 4 focus on specific drugs that are subject to therapeutic drug monitoring (aminoglycosides, vancomycin, theophylline, digoxin, phenytoin) and discuss case studies. This text is presented very well, its layout is logical and clear, and every lesson builds appropriately upon the preceding ones.

Biopharmaceutics and Pharmacokinetics A Treatise by Brahmankar D M, Jaiswal S B

30th September 2009
Tuesday 09:12 PM
Banaras

Hi friends this book covers the twin disciplines of Biopharmaceutics and Pharmacokinetics have, therefore, been developed with the objective of learning how drugs can be utilized optimally in the treatment of diseases–through design and development of new and better therapeutic moieties, new dosage forms and appropriate dosage regimens. A very good book for undergraduate students of pharmacy.Significant expansion of the chapter on controlled release medication has been made to cover in a broader perspective, the principles employed in the design of such dosage forms, their classification and brief description of the technologies and products delivered by various routes. The concerted attempt was to collectively address the several modern approaches adopted to design the modified drug delivery systems, which is an exciting and highly dynamic area of pharmaceutical research.

Download Link:   http://www.mediafire.com/?qarhwc01636jfqm

Biopharmaceutics and Pharmacokinetics A Treatise by Brahmankar D M, Jaiswal S B

The science and technology associated with pharmacy has progressed enormously over the past few decades. Significant advances in the understanding of diseases have necessitated the need to optimize drug therapy. The concern today is not just to produce elegant and accurate dosage forms but also to ensure that optimum amount of drug reaches the target site at an optimal rate and its concentration is maintained for the entire duration of therapy. A thorough background of the fate of drug after its administration; the rate processes to which it is subjected in the body and its behavior after biotransformation, are thus very essential in addition to the knowledge about its pharmacodynamics.

The chapter on Absorption of Drugs has been dealt with comprehensively as most of its principles also form the basis of drug distribution and elimination. Elaborate treatment of text on Biotransformation of Drugs in chapter 5 is justified since a pharmacy student is well versed with the basic chemistry and enzymology. A brief mention about Bioactivation and Tissue Toxicity has been included at the end of this chapter so that after understanding the mechanisms of drug metabolism, a student will be better placed to appreciate their significance. Prodrugs discussed in chapter 6 give insight into the manner in which chemical formulation techniques can be utilized to overcome some of the inherent biopharmaceutic and pharmacokinetic problems of the active principles. Mathematical treatment of chapters on pharmacokinetics has been kept to at modest level in order not to overburden the students with the complexities of equations and formulae. A brief description of methods usually employed to enhance the bioavailability of a drug from its formulation has been included. In addition to covering various aspects of design of dosage regimens and application of pharmacokinetic principles in clinical situations, the text contains a chapter on Controlled Release Medication to familiarize the students with the principles involved in the design of innovative formulations.