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,...
Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the ...
Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade.
Recently the regulatory review of...
Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster pr...
A particular issue for biopharmaceuticals that has not been addressed comprehensively in any book, is the potential of an immune response to the biopharmaceutical product. That is, the human body marks the drug as a foreign body, and develops antibodies against the drug. These antibodies may be relatively harmless, but may also cross-react with the endogenous compound, causing autoimmunogenicity. Recent adverse experiences in Europe with Janssen-Ortho s blockbuster product Eprex has increased the attention towards potential immunogenicity of biopharmaceuticals, above all from the...
A particular issue for biopharmaceuticals that has not been addressed comprehensively in any book, is the potential of an immune response to the bi...
I have always been interested in chemistry and biology. My undergraduate, graduate, and postdoctoral trainings in pharmacy, medicinal chemistry and pharmacology, respectively, have strengthened this interest and led me to realize that significant advances in medicine have frequently been realized because of research at the chem- try biology interface. I am hoping that this comprehensive volume on recent advances in bioactivation research will stimulate pharmacologists, medicinal chemists, phar- ceutical scientists, and graduate students in these fields and related areas to consider and use...
I have always been interested in chemistry and biology. My undergraduate, graduate, and postdoctoral trainings in pharmacy, medicinal chemistry and ph...
The reader will be introduced to various aspects of the fundamentals of nanotechnology based drug delivery systems and the application of these systems for the delivery of small molecules, proteins, peptides, oligonucleotides and genes. How these systems overcome challenges offered by biological barriers to drug absorption and drug targeting will also be described.
The reader will be introduced to various aspects of the fundamentals of nanotechnology based drug delivery systems and the application of these sy...
Prodrugs are substances administered in an inactive form that is then metabolized in the body in vivo into the active compound. The rationale behind administering prodrugs is to optimize absorption, distribution, metabolism, and excretion of these drugs. Since first described in the 1950s, prodrugs continue to be a fertile area of research. There are a number of small pharmaceutical/biotech companies dedicated to using prodrugs for the delivery of older but problematic drugs as well as to developing broad-based prodrug technologies for application to new and future drugs. These volumes...
Prodrugs are substances administered in an inactive form that is then metabolized in the body in vivo into the active compound. The rationale behin...
In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models...
In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mi...
These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. The volumes fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.
These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. The volumes fill a gap between ...
These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. They fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.
These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. They fill a gap between the aca...
Drug discovery and development is a very complex, costly, and ti- consuming process. Because of the uncertainties associated with predicting the pharmacological effects and the toxicity characteristics of new chemical entities in man, their clinical development is quite prone to failure. In recent years, phar- ceutical companies have come under increasing pressure to introduce new blockbuster drugs into the marketplace more rapidly. Companies have responded to these pressures by introducing new technologies and new strategies to expedite drug discovery and development. Drug discovery and...
Drug discovery and development is a very complex, costly, and ti- consuming process. Because of the uncertainties associated with predicting the pharm...
