Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional

 Pharmacology  Comments Off on Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional
Dec 062019
 

This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry.  It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a product’s lifespan on the market due to patent protection itself (or loss of patent protection) or via regulatory exclusivity. Case examples are discussed to illustrate the importance of keeping up with the ever-changing regulations, and how to interpret them in the context of CI. In addition, there is a section on virtual data rooms (VDRs) which currently function as the cornerstone of due diligence investigations. While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and regulatory affairs professionals in other regions. ​
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Systems Pharmacology and Pharmacodynamics

 Pharmacology  Comments Off on Systems Pharmacology and Pharmacodynamics
Dec 032019
 

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.

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Human Pharmaceuticals in the Environment: Current and Future Perspectives

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Dec 022019
 

Human interaction with the environment remains one of the most pervasive facets of modern society. In a world characterized by rapid population growth, unprecedented global trade and digital communications, energy security, natural resource scarcities, climatic changes and environmental quality, emerging diseases and public health, biodiversity and habitat modifications are routinely touted by the popular press as they canvas global political agendas and scholarly endeavors.
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Color Atlas of Pharmacology 5th Edition

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Nov 292019
 

The Fifth Edition of Luellmann’s Color Atlas of Pharmacology has been extensively revised to include all recent advances and new drugs, and the illustrations have been optimized and updated. Each two-page spread presents concise text on the left complemented by detailed full-color illustrations on the right to help users quickly digest important facts and concepts.

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Radiopharmaceuticals: A Guide to PET/CT and PET/MRI 2nd Edition

 Pharmacology, Radiology  Comments Off on Radiopharmaceuticals: A Guide to PET/CT and PET/MRI 2nd Edition
Nov 282019
 

This book provides a rapid and concise guide to PET (PET/CT and PET/MRI) molecular imaging, concentrating extensive information on PET radiopharmaceuticals in a single volume.
The book reflects the rapid development of several PET tracers over the last decade, as a result of which the “traditional” PET/CT with 18F-FDG, the “cornerstone” of PET imaging, is now only one of several available options, which use different tracers for different diseases. For the same reason, PET imaging is no longer limited to the field of oncology.

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Pharmaceutical Powder Compaction Technology

 Pharmacology  Comments Off on Pharmaceutical Powder Compaction Technology
Nov 242019
 

Compaction of powder constituents―both active ingredient and excipients―is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application.

This unique reference covers:

– The physical structure of pharmaceutical compacts

– Bonding phenomena that occur during powder compaction

– Compression mechanisms of pharmaceutical particles

– Theories and basic principles of powder compaction

New topics include:

– Compaction data analysis techniques

– The migration of powder constituents into commercial manufacture

– Instrumentation for compaction

– Compaction functionality testing, which is likely to become a USP requirement

– Design space for compaction

– Metrics required for scalability in tablet compression

– Interactive compaction and preformulation database for commonly used excipients

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Handbook of Pharmaceutical Excipients Ed 8

 Pharmacology  Comments Off on Handbook of Pharmaceutical Excipients Ed 8
Nov 232019
 

The Handbook of Pharmaceutical Excipients collects together essential data on the physical properties of excipients as well as providing information on their safe use and applications. All of the 400+ monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names. It is internationally recognised as the authoritative source of information on pharmaceutical excipients and a comprehensive guide to uses, properties and safety.

Monographs benefit from a standardized, easy-to-use template and include:
Pharmacopeial information from the UK, Europe, Japan and the United States where relevant
Non-proprietary names and synonyms
Chemical name, CAS Registry number, empirical formula, molecular weight
Functional category, applications and incompatibilities
Material description and typical properties
Safety, stability, storage and handling information
Method of manufacture
Related substances
Primary references
Editorial comments
Authors details and revision date

Changes to this new edition:
Contains revised and updated monographs
20 + new monographs including amino acids Arginine, Proline and Asparagine
Includes newly added Raman spectra for many excipients
New chapter content including information on excipients in oral solid dose formulations, and pediatric formulations

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Essentials of Pharmacy Law

 Pharmacology  Comments Off on Essentials of Pharmacy Law
Nov 212019
 

This book is a compilation and commentary of selected laws and regulations pertaining to the general practice of pharmacy in the United States. It is designed to be of assistance to practicing pharmacists, those seeking licensure by reciprocity, and other interested healthcare professionals.
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Space Pharmacology

 Pharmacology  Comments Off on Space Pharmacology
Nov 192019
 

“Space Pharmacology” is a review of the current knowledge regarding the use of pharmaceuticals during spaceflights. It is a comprehensive review of the literature, addressing each area of pharmacokinetics and each major physiological system in turn. Every section begins with a topic overview, and is followed by a discussion of published data from spaceflight, and from ground experiments meant to model the spaceflight situation. Includes a discussion looking forward to the new medical challenges we are likely to face on longer duration exploration missions. This book is a snapshot of our current knowledge that also highlights areas of unknown.
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Antibacterial Drug Discovery to Combat MDR: Natural Compounds, Nanotechnology and Novel Synthetic Sources

 Pharmacology  Comments Off on Antibacterial Drug Discovery to Combat MDR: Natural Compounds, Nanotechnology and Novel Synthetic Sources
Nov 172019
 

This book compiles the latest information in the field of antibacterial discovery, especially with regard to the looming threat of multi-drug resistance. The respective chapters highlight the discovery of new antibacterial and anti-infective compounds derived from microbes, plants, and other natural sources. The potential applications of nanotechnology to the fields of antibacterial discovery and drug delivery are also discussed, and one section of the book is dedicated to the use of computational tools and metagenomics in antibiotic drug discovery. Techniques for efficient drug delivery are also covered. The book provides a comprehensive overview of the progress made in both antibacterial discovery and delivery, making it a valuable resource for academic researchers, as well as those working in the pharmaceutical industry.
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