Monday 10 November 2008

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


Written by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation, and process development aspects of product development. The contributing authors share their experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features.




Pharmacokinetics in Drug Discovery and Development



Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference. After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.



Practical Guide to Clinical Data Management


Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. Clinical data managers have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers readers through the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. It helps readers establish GCP, manage laboratory data, ensure that DMB systems are in compliance with federal regulations, and deal with the kinds of clinical data that can cause difficulties in database applications.

Polymers in Drug Delivery



http://rapidshare.com/files/160142693/tpoly_dd.zip

Nanoparticulate Drug Delivery Systems




Since the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery. This expertly written guide addresses the scientific methodologies, formulation, processing, applications, recent trends, and emerging technologies in the research of nanoparticulate drug delivery systems (NPDDS). It extensively covers applications of NPDDS, including lipid nanoparticles for dermal applications, nanocarriers for the treatment of restenosis, ocular, central nervous system, and gastrointestinal applications, and use as an adjuvant for vaccine development

Cosmetic Formulation of Skin Care Products



Specifically written to meet the needs of the cosmetic chemist and engineer, this reference outlines the latest technologies and issues pertinent to the development novel skin care products including advances in formulation and development, raw materials and active ingredients, compound testing, and clinical assessment. Organized by product category, then by body application area, this guide supplies all one needs to know to create effective skin care products for men and women in a diverse range of ethnic populations.

Sunday 9 November 2008

Troubleshooting LC Systems: A Comprehensive Approach to Troubleshooting LC Equipment and Separations



Major advances in instrumentation and technology have made high-performance liquid chromatography (HPLC) a pervasive tool in virtually all areas of chemical and biomedical research today. Despite HPLC's enormous growth, technical problems still bedevil most users at least occasionally.Based on their immensely successful short courses, Dolan and Snyder's landmark new book --Troubleshooting LC Systems--now makes available to every practicing chromatographer the authors' wealth of expertise from years of hands-on troubleshooting of real-world LC problems--problems that routinely cause crises and unproductive downtime in nearly every lab.Believing that successful troubleshooting requires an understanding of the basics, Dolan and Snyder open by setting forth all the fundamental principles of LC operation, then move on to a microscopic description of all the elements of LC devices, to lay out their optimal preventive maintenance routines, and ultimately to offer an unprecedentedly thorough treatment of each and every facet of troubleshooting.Displaying a special tutorial mastery--honed to a fineness during their ongoing teaching and consulting activities, and a well-received feature column in LC Magazine--the book's chapters cover: automation and robotics • approaches to troubleshooting • reactions of samples • basic separation techniques • valves, tubing, syringes • band broadening and tailing • preventive maintenance • column packing and flushing • individual LC modules • troubleshooting principles • reagents and buffering • specific problems in separation • ghost and vacancy peaks • quantitation and calibration • pumps, seals, and pistons • gradient elution problems • column composition • concentration and blockages • sample cleanup • temperature and mixing effects • detectors and recorders • column packing and flushing.In short, Dolan and Snyder's eminently practical new guide to Troubleshooting LC Systems is an essential laboratory handbook--one that empowers expert and novice chromatographer alike to solve every sort of practical laboratory problem on a day-to-day basis. No one using an LC system should be without it!

Modern Practice of Gas Chromatography


The bible of gas chromatography-offering everything the professional and the novice need to know about running, maintaining, and interpreting the results from GC Analytical chemists, technicians, and scientists in allied disciplines have come to regard Modern Practice of Gas Chomatography as the standard reference in gas chromatography. In addition to serving as an invaluable reference for the experienced practitioner, this bestselling work provides the beginner with a solid understanding of gas chromatographic theory and basic techniques.This new Fourth Edition incorporates the most recent developments in the field, including entirely new chapters on gas chromatography/mass spectrometry (GC/MS); optimization of separations and computer assistance; high speed or fast gas chromatography; mobile phase requirements: gas system requirements and sample preparation techniques; qualitative and quantitative analysis by GC; updated information on detectors; validation and QA/QC of chromatographic methods; and useful hints for good gas chromatography.As in previous editions, contributing authors have been chosen for their expertise and active participation in their respective areas. Modern Practice of Gas Chromatography, Fourth Edition presents a well-rounded and comprehensive overview of the current state of this important technology, providing a practical reference that will greatly appeal to both experienced chomatographers and novices

Thursday 6 November 2008

Handbook of Pharmaceutical Analysis by HPLC, Volume 6

High pressure liquid chromatography frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening,* A complete reference guide to HPLC* Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development* Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling



Friday 24 October 2008

Handbook of Membrane Separations: Chemical, Pharmaceutical, Food, and Biotechnological Applications


The Handbook of Membrane Separations: Chemical, Pharmaceutical, and Biotechnological Applications provides detailed information on membrane separation technologies as they have evolved over the past decades. To provide a basic understanding of membrane technology, this book documents the developments dealing with these technologies. It explores chemical, pharmaceutical, food processing and biotechnological applications of membrane processes ranging from selective separation to solvent and material recovery. This text also presents in-depth knowledge of membrane separation mechanisms, transport models, membrane permeability computations, membrane types and modules, as well as membrane reactors




Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-Soluble Drugs


Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem of major significance, the pharmaceutical industry has been slow to apply and further develop this technology. This title provides a comprehensive summary of the theoretical and practical aspects of oral lipid-based formulations for use in industry, and provides further insights into a developing technology expected to assume increasing prominence in years to come.



Microencapsulation: Methods and Industrial Applications, Second Edition


Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of nanotechnology.

Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products


The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products.


Validation of Pharmaceutical Processes, 3rd Edition



Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title · provides an in-depth discussion of recent advances in sterilization · identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions · explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results · blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions


Handbook of Pharmaceutical Granulation Technology, Second Edition


Applying basic theories to industrial practices in pharmaceutical development, this Second Edition explains how new and emerging technologies are utilized in the production of pharmaceutical granulation-demonstrating cost-effective strategies to manufacture solid-dosage forms with consistent physical properties while complying with current regulatory requirements. New chapters cover process modeling, scale-up considerations, rapid release granulation techniques, melt granulation and pelletization, effervescent granulation, rapid release, and process analytical technology. Updated sections cover the theory of granulation from an engineering perspective and the regulatory standards.


Goodman & Gilman's The Pharmacological Basis of Therapeutics



The undisputed leader in medical pharmacology, without equal. Updated to reflect all critical new developments in drug action and drug-disease interaction. This is the “desert island” book of all medical pharmacology—if you can own just one pharmacology book, this is it.


Pharmacovigilance, 2nd edition



Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. .
The editors and contributors are of excellent standing within the pharmacovigilance community
The text provides exemplary coverage of all the relevant issues
The definitive book on the subject


Aerosols Handbook: Measurement, Dosimetry, and Health Effects




As more attention is dedicated to understanding the occupational health risks associated with the industrial manufacture and use of nanotechnology, Aerosols Handbook: Measurement, Dosimetry, and Health Effects is a timely presentation of the latest research in the field of aerosol science. The book covers a multitude of topics on indoor, outdoor, and industrial aerosols, including aerosol measurement, deposition, particle size distribution, and biokinetic processes. Where harmful exposure to ultrafine particles may occur through inhalation, dermal contact, and ingestion, this book discusses how the size, shape, and chemical properties of particles affect aerosol deposition in the lungs, possibly other organs, and the overall toxicity. The book covers all relevant aspects of aerosols, from epidemiology to molecular biology, and emphasizes the importance of accurate aerosol measurement. The authors discuss Chernobyl accident and miners' lungs in detail to illustrate the effects of radioactive aerosols. The final section focuses on the health effects of specific aerosols, such as diesel aerosols and ultrafine particles. By converging research from both radioactive and non-radioactive aerosols, the editors give the book a unique and more complete perspective of how aerosols behave in the lungs. Aerosols Handbook: Measurement, Dosimetry, and Health Effects is an essential resource for those who study exposure, dosages, and toxicity to develop treatments for exposure, reduce air pollution, and establish better safety regulations, particularly in industries using nanotechnologies.






Medicinal Chemistry

The qualified success and general appeal of Medicinal Chemistry is not only confined to the Indian subcontinent, but it has also won an overwhelming popularity in other parts of the world. Specific care has been taken to maintain and sustain the fundamental philosophy of the textbook embracing rigidly the original pattern and style of presentation with a particular expatiated treatment of synthesis of potential medicinal compounds for the ultimate benefits of the ?teachers and the taught? alike.The present thoroughly revised and skilfully expanded Fourth Edition essentially contains three new and important chapters, namely : Molecular Modeling and Drug Design (Chapter 3), Adrenocortical Steroids (Chapter 24), and Antimycobacterial Agents (Chapter 26) so as to make the textbook more useful to its readers.With the advent of thirty chapters the present updated form of Medicinal Chemistry will prove to be an asset for M.Pharm./B.Pharm. Degree Students, M.Sc. Pharmaceutical Chemistry, M.Sc. Applied Chemistry and M.Sc. Industrial Chemistry throughout the Indian Universities.Medicinal Chemistry appears as a newly designed and artistically presented in a two-colour scheme so as to facilitate a distinctly more effective use of the book.This highly readable, lucid, handy, and exceptionally knowledgeable textbook will definitely win a better, bigger, and confident place for itself amongst its valued readers.

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Pharmaceutical Biotechnology


Pharmaceutical Biotechnology


TayLor and Francis ISBN: 0849318734 Second Edition - 2006 PDF 432 pages 15 MB rapidsharePharmaceutical Biotechnology explores the development of protein-based therapeutic substances.• Provides a working knowledge of the preparation, stability, and formulation of protein and peptide drugs• Examines the successful evolution of humanized monoclonal antibodies (MAbs) to treat rheumatoid arthritis and other diseases• Considers the currently disappointing results of genetic engineering and genomics that have isolated disease-responsible genes without significant clinical effect to date• Looks at the market and scientific reasons behind the failure of many biotechnology products to live up to their hype• Discusses regulatory and compendial issues and concludes with a look at future challenges facing biotechnology



Pharmaceutical Product Development


Pharmaceutical Product Development: In Vitro-In Vivo Correlation (Drugs and the Pharmaceutical Sciences)

In thelast two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and pharmacokinetics are collaborating to address physicochemical and biological issues in the early stages of development to avoid problems in later stages. In Vitro-In Vivo Correlation (IVIVC) is a multidisciplinary tool that has been successfully applied in testing the effectiveness of a drug substance. The only comprehensive guide available on IVIVC, this source illustrates the emerging importance of IVIVC in the drug development process, and covers the most recent advances and regulatory perspectives on the role of IVIVC in the pharmaceutical industry.




 

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