This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By...
This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applicatio...
This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs.
Specific topics covered in this book include:
Solution, suspension, gel, nanoparticle, microparticle, and implant dosage forms
Refillable and microneedle devices
Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery
Physical methods including iontophoresis for drug delivery
Rational selection of...
This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including s...
This book is intended to cover the fundamental and practical aspects of regulated bioanalysis. The editors are seeking leading scientists in the field to participate in the development of this book, which we envision as a -one of a kind- contribution to our field. The book is intended for students in the pharmaceutical sciences, chemistry, biology and related scientific disciplines interested in bioanalysis, as well as working scientists new to the field of regulated bioanalysis. It will also serve as a primer for those experienced in the field. The depth of the book will seek to give its...
This book is intended to cover the fundamental and practical aspects of regulated bioanalysis. The editors are seeking leading scientists in the fi...
In vivo target site concentrations are probably the most important determinant of drug effects. Traditionally, linking drug concentrations to drug effects has been accomplished by modelling blood-derived data, mostly because a direct quantification of tissue concentrations has been beyond technical reach. Today, a direct measurement of target site concentrations is possible by employing microdialysis or complementary approaches such as imaging technologies. Microdialysis, initially conceived in the 1970ies, has become a standard tool in drug development. This comprehensive overview of current...
In vivo target site concentrations are probably the most important determinant of drug effects. Traditionally, linking drug concentrations to drug eff...
This volume will consider one of ICH's major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why...
This volume will consider one of ICH's major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenic...
Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:
Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines
Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable...
Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile pr...
This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs.
Specific topics covered in this book include:
Solution, suspension, gel, nanoparticle, microparticle, and implant dosage forms
Refillable and microneedle devices
Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery
Physical methods including iontophoresis for drug delivery
Rational selection of...
This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including s...
Transporters in Drug Development examines how membrane transporters can be dealt with in academic-industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. The book describes methods and examples of in vitro characterization of single transporters in the intestines, liver and kidneys as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters' impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The...
Transporters in Drug Development examines how membrane transporters can be dealt with in academic-industrial drug discovery and pharmaceutic...
The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve...
The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through...
There have been tremendous advancements in application of modeling and simulation (M&S) in drug development during the last decade. The pharmaceutical companies started to pay more attention to implement simulation exercises in drug development in order to achieve cost effectiveness. The Food and Drug Administration (FDA) published a white paper titled, Critical Path Initiatives, in March 2004. This puts forward model based drug development that calls for use of quantitative M&S to facilitate informed decisions. The European Medicines Agency (EMEA) also encourages use of simulations in...
There have been tremendous advancements in application of modeling and simulation (M&S) in drug development during the last decade. The pharmaceuti...
