Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

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http://rapidshare.com/files/52607976/Excipient_Deve_Pharma.zip

Powder Sampling and Particle Size Determination

Powder technology is a rapidly expanding technology and nowhere more than in particle characterization. There has been an explosion of new particle measuring techniques in the past ten year particularly in the field of on-line measurement. One of the main aims of this book is to bring the reader up-to-date with current practices. One important area of interest is the improvements in on-line light scattering instruments and the introduction of ultrasonic on-line devices. Another is the introduction of on-line microscopy, which permits shape analysis in conjunction with particle sizing.

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

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Drug Safety Evaluation

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated.

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

Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

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http://rapidshare.com/files/51526582/Drug_Safety_Evaluation.zip

Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics(Biotechnology:Pharmaceutical Aspects)(Biotechnology:Pharmaceutical Aspects

Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.

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http://rapidshare.com/files/50699641/Solvent_Sys_in_Pharma_Biopharma.zip

Stability of Drugs and Dosage Forms

Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.

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http://rapidshare.com/files/50694531/stability_drugs_dosage_forms.zip

Handbook of Pharmaceutical Excipients

The Handbook of Pharmaceutical Excipients is a comprehensive, uniform guide to the uses, properties, and safety of pharmaceutical excipients. It collects in a systematic and unified manner, essential data on the physical and chemical properties of excipients. Information has been assembled from a variety of sources, including the primary literature and excipients manufacturers. Personal observations and comments from contributors are also included.

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http://rapidshare.com/files/50715179/1582120587_Pharmaceutical_Excipients.rar