Pharmaceutical Anti-Counterfeiting: Combating the Real by Mark Davison

By Mark Davison

This booklet overviews and integrates the enterprise and technical matters that pharmaceutical businesses want to know for you to strive against the main worldwide challenge of counterfeit medications. as well as dialogue of the issues, the writer Davison addresses analytical suggestions scientists use to realize counterfeits and provides a few attainable options to the specter of counterfeit scientific items. assurance strikes from simple evaluation of the matter, charges / dangers to shoppers (toxic items, distrust of drug businesses) and enterprise (revenue loss, public trust), govt oversight and law, authentication thoughts (packaging, analytical techniques), product monitoring and provide chain, and case experiences from all over the world.

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Pharmacokinetic Optimization in Drug Research: Biological, by Bernard Testa, Han van de Waterbeemd, Gerd Folkers, Richard

By Bernard Testa, Han van de Waterbeemd, Gerd Folkers, Richard Guy

During this age of combinatorial chemistry and high-throughput applied sciences, bioactive compounds known as hits are came upon via the hundreds of thousands. even though, the line that leads from hits to guide compounds after which to pharmacokinetically optimized medical and drug applicants is particularly lengthy certainly. therefore, the screening, layout, and optimization of pharmacokinetic homes has turn into the bottleneck and a huge problem in drug study. To shorten the time-consuming develop-ment and excessive expense of attrition of lively compounds finally doomed by means of hidden pharmacokinetic defects, drug researchers are coming to include structure-permeation, structure-distribution, structure-metabolism, and structure-toxicity family members into drug-design recommendations. To this finish, robust organic, physicochemical, and computational methods are being built whose ambitions are to extend the scientific relevance of drug layout, and to cast off once attainable compounds with unfavourable physicochemical homes and pharmacokinetic profiles. Toxicological matters also are of extreme significance during this paradigm.
there has been, therefore, an pressing want for a ebook overlaying this box in an authoritative, didactic, complete, authentic, and conceptual demeanour. during this paintings of special breadth and intensity, overseas experts and working towards specialists from academia and current the main smooth organic, physicochemical, and computational concepts to optimize gastrointestinal absorption, protein binding and distribution, mind permeation, and metabolic profile. The organic thoughts emphasised within the e-book contain cellphone cultures and high-throughput displays. The physicochemical suggestions specialise in the choice and interpretation of solubility, lipophilicity, and comparable molecular homes as elements and predictors of pharmacokinetic bahavior. specific awareness is paid to the lipophilicity profiles of ionized compounds, to lipophilicity measurements in anisotropic media (liposomes/water, IAM columns), and to permeability throughout man made membranes. Computational techniques contain digital screening, molecular modelling, lipophilicity, and H-bonding fields and their value for structure-disposition relations.
This booklet is either approximately theoretical and technological breakthroughs. hence, molecular homes are meditated from a twin viewpoint, specifically a) their interpretation in organic and/or physicochemical phrases, and b) their price in screening, lead optimization, and drug-candidate selection.
as well as its 33 chapters, the booklet features a CD-ROM containing the invited lectures, oral communications and posters (in complete model) provided on the moment LogP Symposium, 'Lipophilicity in Drug Disposition -- sensible and Computational techniques to Molecular houses on the topic of Drug Permeation, Disposition and Metabolism', held on the college of Lausanne in March 2000. Content:

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Global Pharmaceutical Marketing: A Practical Guide to Codes by Judith Grice

By Judith Grice

Around the world, there are various Codes of Practice/Conduct for the pharmaceutical that make sure the self-regulates to advertise the precise use of medications via working in a qualified, moral and obvious demeanour and making sure excessive standards.The goal of this ebook is to help the knowledge of the various pharmaceutical Codes of Practice/Conduct in the course of the global. It includes an outline of the information for the merchandising of pharmaceutical items in all geographical areas.Each part incorporates a ''general overview'' supplying a dialogue on that exact Code of perform and differences/similarities with different international locations.

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Quantitative Evaluation of Safety in Drug Development : by Qi Jiang, H. Amy Xia

By Qi Jiang, H. Amy Xia

State-of-the-Art tools for Drug safeguard Assessment

Responding to the elevated scrutiny of drug safeguard lately, Quantitative assessment of defense in Drug improvement: layout, research and Reporting explains layout, tracking, research, and reporting concerns for either scientific trials and observational reviews in biopharmaceutical product improvement. It offers the most recent statistical tools for drug safeguard evaluation.

The book’s 3 sections specialize in research layout, safeguard tracking, and knowledge evaluation/analysis. The e-book addresses key demanding situations throughout regulatory firms, undefined, and academia. It discusses quantitative ways to defense evaluate and danger administration in drug improvement, masking Bayesian tools, powerful protection photographs, and risk-benefit evaluation.

Written through a workforce of skilled leaders, this booklet brings the main complex wisdom and statistical equipment of drug safeguard to the statistical, medical, and safeguard group. It stocks most sensible practices and stimulates additional study and method improvement within the drug defense area.

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Biological Therapeutics by Daniel A. Brook, Ben Greenstein

By Daniel A. Brook, Ben Greenstein

An advent to what's arguably the main interesting and fastest-growing department of pharmaceutical technological know-how this present day: the remedy of illness utilizing organic medicinal drugs derived from residing plant and animal tissues. All different types of organic therapeutics are coated during this complete evaluation. bankruptcy gains comprise: * historic introductions * an summary of the medicine and their mechanisms of motion and makes use of * examples of inauspicious reactions * case reviews This publication is key studying for scientific and pharmacy scholars, in addition to practitioners and prescribers aiming to take care of to this point with the most recent advancements in organic medications.

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Pharmaceutical Process Scale-Up by Michael Levin

By Michael Levin

Scale-up is usually outlined because the strategy of expanding batch measurement. Scale-up of a procedure is also considered as a strategy for utilizing an identical approach to assorted output volumes. there's a refined distinction among those definitions: batch measurement growth doesn't continually translate right into a measurement bring up of the processing volume.Keeping speed with the elevated effect of PAT within the pharmaceutical undefined, this thoroughly up-to-date reference spans the most recent examine and rules, applied sciences, and professional recommendations for each major element of pharmaceutical approach scale-up-clearly introducing readers to the theoretical inspiration of dimensional research to quantify comparable procedures on various scales.

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Development of FDA-Regulated Medical Products - Prescription by Elaine Whitmore

By Elaine Whitmore

Many adjustments to the type and law of prescribed drugs, biologics, and clinical units have happened because the prior variation of this publication was once released in 1997 below the name Product improvement making plans for overall healthiness Care items Regulated through the FDA. This revised variation contains: up-to-date proof and figures; enlargement of matters that experience grown extra severe, equivalent to medical results, human elements, and advertising pursuits; and extra new subject matters corresponding to the position of product improvement in danger research, remembers, and product legal responsibility. the writer additionally covers the nutrients and Drug Administration’s Modernization Act (FDAMA), in addition to discussions on highbrow estate, pharmacoeconomics, and technological and scientific developments. This booklet is meant as a beginning for an individual keen on product improvement of prescription drugs, biologics, or clinical units undefined. valuable references comprise a word list, acronyms, and a listing of precious assets.
Content:
entrance subject
• checklist of Figures and Tables
Prefaces
• Abbreviations
• desk of Contents
•Part I. distinct demanding situations in scientific Product Development• 1. Healthcare within the usa
2. it isn't Your Father's FDA: The "Modernization" of scientific Product rules
three. Product legal responsibility and Product improvement
•Part II. Bringing a brand new clinical Product to industry four. evaluate of the Approval methods for medications, Biologics, and scientific units
• five. Designing-in caliber
6. Designing-out catastrophe: chance research
7. recollects, Revocations, and Withdrawals
• eight. Human elements and the character of Relationships: Minimizing scientific blunders
nine. Is it secure and Does it Work?: comparing safeguard and Efficacy in medical Trials
10. How a lot is the Product rather Worth?: results study, Pharmacoeconomics, and controlled Care
•Part III. Product improvement making plans eleven. types and Metaphors: Product improvement and the Product improvement association
12. elements of Product improvement making plans: The Product improvement strategy
thirteen. parts of Product improvement making plans: improvement Portfolio administration
• 14. elements of Product improvement making plans: know-how evaluate
• 15. elements of Product improvement making plans: expertise Forecasting
sixteen. extra for the Laundry record: advertising and marketing, Patents, Budgets, video games, and caliber
17. the place can we cross from the following?
• Endnotes
• thesaurus
• assets
Index

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Pharmaceutical experimental design and interpretation by N. Anthony Armstrong

By N. Anthony Armstrong

Thoroughly revised and up to date, Pharmaceutical Experimental layout and Interpretation, moment version explains the key equipment of experimental layout and review corresponding to multivariate, sequential, and vital elements research. With new sections on neural networks, man made intelligence, fractional designs, and optimization options, this resource will turn out necessary to a person desirous about the layout and execution of pharmaceutical examine reviews and the translation of research info.

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