Category: Medical Ebooks

Development and Approval of Combination Products: A by Evan B. Siegel

By Evan B. Siegel

A step by step, built-in strategy for profitable, FDA-approved mix drug products

utilizing a confirmed built-in method of blend drug improvement, this e-book courses you step-by-step via the entire preclinical, medical, and production phases. Written from an FDA regulatory viewpoint, the e-book not just allows you to carry a winning mixture drug product to industry, it additionally units forth the most productive and powerful route to FDA approval.

The e-book starts with an introductory bankruptcy featuring definitions and simple regulatory rules of mixture items. subsequent, it stories production and controls, preclinical trying out types, pharmacology, medical checking out, regulatory submissions, FDA reports, and approvals. one of the key issues tested are:
* The pharmacology, safeguard pharmacology, and toxicology helping human medical trials of mix products
* ways to scientific trial protocol layout and execution
* Chemical, physicochemical, and analytical features of producing controls and validation that result in strong parts for mixture products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization

Case reviews regarding such real mixture items as Mylotarg, Herceptin, and HercepTest assist you larger know how to enforce the author's useful instructions. References on the finish of every bankruptcy help you locate additional info on any degree of the improvement, production and approval processes.

This ebook is perfect for researchers, regulators, lecturers, venture managers, and bosses inquisitive about the advanced strategy of mix product improvement. not just does itoffer a accomplished advisor to the technical elements of the sector, it additionally integrates all ofthese technical features right into a unified, powerful method of support be sure a winning, licensed product.Content:
Chapter 1 review of mixture items improvement and Regulatory assessment (pages 1–4): Evan B. Siegel
Chapter 2 precise Regulatory techniques to improvement, assessment, and Approval (pages 5–75): James Barquest
Chapter three Nonclinical strategies for winning Characterization and improvement of blend Drug items (pages 77–111): Duane B. Lakings
Chapter four scientific Pharmacology and scientific improvement of mix items (pages 113–170): Chaline Brown
Chapter five Regulatory technique issues for Chemistry, production, and Controls: An built-in technique (pages 171–200): Patrick L. DeVillier

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Handbook of Pharmaceutical Manufacturing Formulations Volume by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

The fourth quantity within the six-volume guide of Pharmaceutical production Formulations, this e-book covers semi-solid medicinal drugs. It comprises ointments, creams, gels, and suppositories, from publicly on hand yet extensively dispersed details from FDA New Drug functions (NDA), patent functions, and the BASF booklet of conventional formulations. each one access starts with a completely established scaleable production formulation that comes with compendial specification requirement for every element, in-process controls for production and liberate of product, a precis of producing technique, and information of packaging.

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Modern Pharmaceutics. Applications and Advances by Alexander T. Florence, Juergen Siepmann

By Alexander T. Florence, Juergen Siepmann

Glossy Pharmaceutics edited via Gilbert Banker and Christopher Rhodes has turn into a vintage within the box. it truly is renowned and has been good obtained on a world foundation, necessitating the ebook of this 5th variation. the current editors took at the tough job of following within the footsteps of the founding editors and their affiliates with a few trepidation.

Given the passage of time and the expansion and alter within the box, the e-book has been divided into volumes: uncomplicated rules and platforms and functions and Advances.

Applications and Advances is especially a textbook and complex reference resource of pharmaceutics, which specialise in the center of the topic that's key to pharmacy.

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Modern Pharmaceutics, Fifth Edition, Volume 2: Applications by Alexander T. Florence, Juergen Siepmann

By Alexander T. Florence, Juergen Siepmann

Quantity 2 discusses the purposes and techniques in complicated drug supply platforms, together with transdermal, pulmonary, and ocular routes. moreover, it describes the impression of the shift to personalised drugs within the fields of pharmaceutical biotechnology, pharmacogenomics, and nanotechnology.DELIVERY of substances through THE PULMONARY course - Covers the interplay among the actual chemistry of the formulations and administered debris with the anatomy of the bronchial and alveolar regionsPEDIATRIC AND GERIATRIC PHARMACEUTICS - Addresses the physiological adjustments, layout, and construction of formulations for every of those sufferer populationsBIOEQUIVALENCE overview - Covers how you can degree the bioequivalence of a similar drug in quick-release pill, pill, or sustained-release shape, in addition to branded and conventional systemsTARGET-ORIENTED supply platforms - Explores the demanding situations of designing supply structures that focus on particular websites within the physique and reason fewer unwanted effects via interplay with non-diseased tissues

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Data Mining in Drug Discovery by Rémy D. Hoffmann, Arnaud Gohier, Pavel Pospisil, Raimund

By Rémy D. Hoffmann, Arnaud Gohier, Pavel Pospisil, Raimund Mannhold, Hugo Kubinyi, Gerd Folkers

Written for drug builders instead of computing device scientists, this monograph adopts a scientific method of mining scientifi c info assets, protecting all key steps in rational drug discovery, from compound screening to steer compound choice and custom-made medication. in actual fact divided into 4 sections, the 1st half discusses the several info assets to be had, either advertisement and non-commercial, whereas the following part seems on the function and price of information mining in drug discovery. The 3rd half compares the commonest purposes and techniques for polypharmacology, the place info mining can considerably improve the learn attempt. the ultimate portion of the e-book is dedicated to platforms biology techniques for compound trying out.
Throughout the booklet, commercial and educational drug discovery techniques are addressed, with individuals coming from either components, allowing an educated choice on while and which facts mining instruments to exploit for one's personal drug discovery project.

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Crash Course Respiratory System by Sarah Hickin

By Sarah Hickin

Crash direction - your potent daily examine better half PLUS the suitable antidote for examination rigidity! store time and be guaranteed you could have all of the details you wish in a single position to excel in your path and attain examination luck.

A successful formulation now for over 15 years, every one quantity has been fine-tuned and entirely up-to-date, with a much better format adapted to make your existence more uncomplicated. specially written through senior scholars or fresh graduates - those that comprehend what's crucial for examination good fortune - with all details completely checked and caliber guaranteed by means of specialist school Advisors, the result's a sequence of books which precisely meets your wishes and also you recognize you could belief.

This quantity within the crucial zone of respiration medication offers a coherent trip from uncomplicated technology to scientific evaluation and respiration pathology. The cautious inclusion of move referencing and the very newest directions will show you how to speedy hyperlink the foremost elements of technological know-how and scientific drugs in an evidence-based manner. Whether you're revising for simple technology checks or are at the wards searching for medical info with a pathophysiological concentration, this re-creation is for you!

  • More than one hundred seventy illustrations current medical, diagnostic and functional details in an easy-to-follow manner
  • Friendly and available method of the topic makes studying in particular easy
  • Written through scholars for college students - authors who comprehend examination pressures
  • Contains ‘Hints and assistance’ bins, and different invaluable aide-mémoires
  • Succinct insurance of the topic allows ‘sharp concentration’ and effective use of time in the course of examination preparation
  • Contains a completely up-to-date self-assessment part - excellent for honing examination talents and self-testing
  • Self-assessment part totally up to date to mirror present examination requirements
  • Contains ‘common examination pitfalls’ as instructed by way of faculty

Crash path - your potent daily learn better half PLUS the suitable antidote for examination pressure! store time and be guaranteed you have got all of the details you wish in a single position to excel in your direction and attain examination good fortune.

A successful formulation now for over 15 years, every one quantity has been fine-tuned and entirely up to date, with a higher format adapted to make your lifestyles more uncomplicated. specifically written by way of senior scholars or contemporary graduates - those that comprehend what's crucial for examination good fortune - with all info completely checked and caliber guaranteed via professional college Advisors, the result's a chain of books which precisely meets your wishes and also you be aware of you could belief.

This quantity within the crucial quarter of respiration medication offers a coherent trip from easy technology to scientific overview and breathing pathology. The cautious inclusion of move referencing and the very most up-to-date guidance will allow you to quick hyperlink the foremost facets of technological know-how and medical drugs in an evidence-based manner. Whether you're revising for easy technological know-how checks or are at the wards searching for medical info with a pathophysiological concentration, this new version is for you!

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Succeeding in your GPST stage 2 situational judgement tests by Nicole Corriette, Matt Green

By Nicole Corriette, Matt Green

Situational Judgment checks (SJTs) or specialist Dilemmas shape an important a part of the GPST recruitment technique and but many medical professionals do not need skilled questions of this kind less than exam stipulations. it truly is for that reason crucial that applicants sitting the GPST level 2 examination have a transparent knowing of ways to process questions of this kind as bad functionality during this part will very likely lead to no longer progressing to the level three choice day. This interactive booklet, which includes precise suggestions, and over 70 perform questions (including specified causes of the entire answers), goals to assist medical professionals organize for and effectively entire their GPST degree 2 examination. during this publication, Nicole Corriette and Matt eco-friendly: - Describe the context of Situational Judgement assessments in the GPST degree 2 choice approach - discover a number of the moral ideas it's essential to give some thought to while answering a majority of these questions - Set out tips to technique a few of the query varieties you'll be confronted with - supply over 70 inquiries to placed into coaching every little thing that you simply study - specified motives of the right kind solutions also are supplied to assist your arrangements This attractive, effortless to take advantage of and complete e-book is vital interpreting for somebody fascinated about excelling of their GPST level 2 exam and effectively progressing to level three of the GPST choice procedure

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Critical Resection Length and Gap Distance in Peripheral by Gerhard Orf M.D. (auth.)

By Gerhard Orf M.D. (auth.)

The moment international conflict gave upward push to a formerly unimaginable variety of peripheral nerve accidents. simply afterward did those accidents get together renewed extensive study during this box of neurosurgery. one of the components that have promoted this improvement is the working microscope with extra subtle surgical suggestions. in fact, surgical procedure of peripheral nerve accidents in peacetime isn't to be in comparison with that during wartime. simply fast wound therapeutic permits a secondary suture to be played at a positive time, after approximately 4 weeks. along with mostly the illness of substance isn't as nice as in conflict accidents, during which the so-called "critical resection size" (Seddon) was once the reason for the best problems and consti­ tuted the the most important main issue to solid luck. The skilled surgeons of the second one global warfare consistently knew that the desired dimensions have been a ways too nice for the serious resection size. they can in simple terms hotel to trying a suture even if there has been a very good hole be­ tween the ends of the nerves. certain info used to be now not on hand on direct harm to the axis cylinder or alteration as a result of vascular elements while stretching many of the nerves, in particular throughout the later mobilization of joint decompressions. for my part, the experimental investigations of the writer could make a contribution right here. The accurately accomplished and afterwards conscientiously analyzed experiments seem probably to be acceptable to human stipulations as regards their possibilities of overall nerve length.

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