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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems
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Powder Sampling and Particle Size Determination
Schools of powder technology are common in Europe and Japan but the importance of this subject has only recently been recognised in America with the emergence of the Particle Research Centre (PERC) at the University of Florida in Gainsville.
- Details all the latest developments in powder technology
- Written by established authority on powder technology
- A comprehensive text covering all aspects of powder technology and handling of particulate solids including characterization, handling and applications
Drug Safety Evaluation
Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including:
- Acute toxicity testing in pharmaceutical safety evaluation
- Genotoxicity
- Safety assessment of inhalant drugs
- Immunotoxicology in pharmaceutical development
- Large animal studies
- Evaluation of human tolerance and safety in clinical trials
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Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics(Biotechnology:Pharmaceutical Aspects)(Biotechnology:Pharmaceutical Aspects
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Stability of Drugs and Dosage Forms
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Handbook of Pharmaceutical Excipients
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Indian Medicinal Plants: An Illustrated Dictionary
In 2004, Springer-Verlag Heidelberg published C.P.Khare’s "Encyclopedia of Indian Medicinal Plants" which contained 400 monographs comprising classical as well as contemporary research findings.
"Indian Medicinal Plants. An Illustrated Dictionary" is the second major one-volume reference work by C.P.Khare which has been dedicated to the distinguished scientist, Dr. A.P.J.Abdul Kalam, who did pioneering work by reviving the glory of medicinal and aromatic plants in Rashtrapati Bhavan.
Scientific monographs of "The Wealth of India" series (17 volumes) have been capsulised in the dictionary and corroborated with the judicious findings of German Commission E, European Cooperative on Phytotherapy (ESCOP) and WHO. Therapeutic leads, active indications and contraindications are salient features of the core text. These are based on herbal pharmacopoeias, compendiums and latest editions of standard reference works like "PDR for Herbal Medicines," "(Laurance) Review of Natural Products", "Natural Medicines Comprehensive Database". Leads for further research have been provided at a number of places.
The Dictionary is the first updated source of Ayurvedic, Unani and Siddha synonyms of their botanical counterparts, after a gap of more than 30 years. The synonyms which appeared in "The Wealth of India" series (1948-1976) and in Chopra’s "Glossary of Indian Medicinal Plants" (1956) have been updated till January, 2007.
More than 2000 medicinal plants of "The Ayurvedic Formulary of India" and "The Ayurvedic Pharmacopoeia of India" and more than 100 species of non-Indian origin, incorporated in "National Formulary of Unani Medicine" have been covered in the Dictionary. Divergent sources of Ayurvedic, Unani and Siddha herbs have been identified and a number of controversies have been sorted out.
Pharmacognosy experts have selected important herbs, which were specially collected from leading pharamaceutical companies and pharmacopoeial laboratories and included in the dictionary as four colour photographs under the "Crude Herb Identification Guide" section. This is a unique feature and makes it an exclusive treat.
The Dictionary has been presented in a user-friendly format, as a compact, handy, easy to use and moderately priced one-volume reference work. It unfolds hidden virtues and potentials of Indian herbs for busy professionals, researchers, practitioners of herbal as well as modern medicine, and library frequenters. It will prove a ready information source for students of botany, economic botany, pharmacy, agricultural and medical sciences, who aspire to have an edge over others and are keen to keep themselves abreast of the times.
Column Handbook for Size Exclusion Chromatography
Key Features
* Evaluate and select columns with confidence for specific applications
* Optimize separations and improve the ruggedness of analytical methods
* Extend the service time of a column
* Establish a quality-control program to ensure consistency in column performance
* Avoid the expense of column damage or purchases that do not give the expected results.
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Effective drug regulation: A multicountry study
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Injectable Dispersed Systems: Formulation, Processing and Performance
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Batch Processes
Reduced time to market, lower production costs, and improved flexibility are critical success factors for batch processes. Their ability to handle variations in feedstock and product specifications has made them key to the operation of multipurpose facilities, and therefore quite popular in the specialty chemical, pharmaceutical, agricultural, and biotechnology-enabled products industries. The editors of Batch Processes analyze the design, development, operations, and control of batch processes - providing answers to the most challenging and pressing problems associated with their use. They present a reference unique in its coverage of both process design and operations management issues. Leading experts from industry and academia contribute chapters that discuss batch process scheduling, design software tools, and the latest technologies, their implementation, and their respective advantages. The book is presented in four parts for easy reference. Part I, Batch Processing General Overview, introduces the topic and discusses batch processing industries. Part II, Batch Processing Design Issues, includes information on conceptual design and synthesis, reactors in bioindustries, distillation, crystallization, and pollution prevention. Part III, Batch Processing Management, informs the reader on modeling and optimization, planning and scheduling, monitoring and control, and supply chain management. Part IV, Future of Batch Processing, offers concluding remarks and contemplates the future of batch processing.
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In Silico Technologies in Drug Target Identification and Validation
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Good Laboratory Practice Regulations, Fourth Edition
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Facility Validation: Theory, Practice, and Tools
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Rules and Guidance for Pharmaceutical Manufacturers and Distributors
Since the 2002 edition of 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors', commonly known as the 'Orange Guide', there have been many changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP). In addition, there is a new Directive dealing specifically with GMP and the Community Code relating to medicinal products for human use (Council Directive 2001/83/EC) has itself been the subject of substantial revision, via amending Directive 2004/27/EC, and these changes have been transposed into UK domestic legislation.
From its first publication in 1971 the 'Orange Guide', has been an essential reference for all involved in the manufacture and distribution of medicines in Europe.
The 'Orange Guide' collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Compliance with Good Manufacturing Practice and Good Distribution Practice requirements is essential in the production and distribution of medicines for human use to safeguard public health and to comply with legislation.
It is of particular relevance to all holders of Manufacturer’s Licences and Wholesale Dealer’s licences and to their Qualified Persons and Responsible Persons, who have a responsibility for ensuring compliance with many of these regulatory requirements.
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Gas Chromatography and Mass Spectrometry
Key Features:
* Condenses and organizes recent and essential information for new and experienced GC/MS users
* Comprehensively indexed and referenced
* Includes practical methods of analysis
* Serves as a text reference for short practical courses on the subject
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International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs, Fifth Edition
This book contains the English language texts of all GMPs, regulations, guidelines, codes, and practices implemented by national and international regulatory authorities that govern the manufacture and testing of biotechnology-derived products, active pharmaceutical ingredients, and pharmaceuticals. Prepared with the cooperation of health authorities worldwide, this resource contains the GMPs in effect in 114 countries, plus GMP regulations of the World Health Organization, including the 1996 WHO GMPs, the European Union, the Association of South East Asian Nations, and the Pharmaceutical Inspection Convention.
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PART - I : http://rapidshare.com/files/46920750/International_Biotechnology_and_Pharmaceutical_GMPS.part1.rar
PART - II: http://rapidshare.com/files/47045149/International_Biotechnology_and_Pharmaceutical_GMPS.part2.rar