Asymmetric synthesis of drugs and natural products

Authors : Nag, Ahindra
Edition :
Year : 2018
Description :

This book focuses on different techniques of asymmetric synthesis of important compounds, such as drugs and natural products. It gives insightful information on recent asymmetric synthesis by Inorganic, Organic and Enzymatic combinations.
Abstract: "This book focuses on different techniques of asymmetric synthesis of important compounds, such as drugs and natural products. It gives insightful information on recent asymmetric synthesis by Inorganic, Organic and Enzymatic combinations


Link Download :  http://downlFAC

The Analysis of Drugs in Biological Fluids

Authors : Chamberlain, Joseph
Edition : 2
Year : 2018
Description :

This new edition focuses on a variety of techniques available for the analysis of drugs in biological fluids. Over 150 figures and tables help to describe the latest advances and give examples of their applications. Current chiral analysis methods as well as discussions on the impact of chirality are described. Practical aspects of bioanalytical work, including many examples of laboratory problems not often reported in the scientific literature, are examined in depth."
Abstract: "This new edition focuses on a variety of techniques available for the analysis of drugs in biological fluids. Over 150 figures and tables help to describe the latest advances and give examples of their applications. Current chiral analysis methods as well as discussions on the impact of chirality are described. Practical aspects of bioanalytical work, including many examples of laboratory problems not often reported in the scientific literature, are examined in depth."--Provided by publisher


Link Download :  http://downl2D

Pharmaceutical Extrusion Technology

Authors : Isaac Ghebre-Sellassie, Charles E. Martin, Feng Zhang, James DiNunzio
Edition : 2
Year : 2018
Description :

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. 
Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms.


Link Download :  httpdownBFA

The Addiction Solution: Treating Our Dependence on Opioids and Other Drugs

Authors : Lloyd Sederer
Edition :
Year : 2018
Description :

A groundbreaking examination of addiction from a psychiatrist and public health doctor, offering practical, proven solutions for individuals, families, and communities dealing with substance use and abuse.

Written with warmth, accessibility, and vast authority, The Addiction Solution is a practical guide through the world of drug use and abuse and addiction treatment. Here, Lloyd I. Sederer, MD, brings together scientific and clinical knowledge, policy suggestions, and case studies to describe our current drug crisis and establish a clear path forward to recovery and health. In a time when so many people are affected by the addiction epidemic, when 142 people die of overdoses every day in the United States, principally from opioids, Sederer’s decades of wisdom and clinical experience are needed more than ever before.

With a timely focus on opioids, Sederer takes us through the proven essentials of addiction treatment and explains why so many of our current policies, like the lingering remnants of the War on Drugs, fail to help drug users, their families, and their wider communities. He identifies a key insight, often overlooked in popular and professional writing about addiction and its treatment: namely, that people who use drugs do so to meet specific needs, and that drugs may be the best solution those people currently have. Writing with generosity and empathy about the many Americans who use illicit and prescribed substances, Sederer lays out specific, evidence-based, researched solutions to the prevention and problems of drug use, including exercise, medications, therapy, recovery programs, and community services. In this challenging time, The Addiction Solution provides practical help, comfort, and hope.


Link Download :  httpdownEBFF

Medicinal Plants : Promising Future for Health and New Drugs

Authors : Parimelazhagan, Thangaraj
Edition : 5
Year : 2018
Description :

This book highlights the importance of traditional medicines, focuses on the standardization of herbal medicine and evaluates opportunities for advancing drug research. It addresses issues in utilization of medicinal plants and shares the importance of herbs in neutraceutics. It provides most competitive techniques being used in research."--Provided by publisher. 
Abstract: "This book highlights the importance of traditional medicines, focuses on the standardization of herbal medicine and evaluates opportunities for advancing drug research. It addresses issues in utilization of medicinal plants and shares the importance of herbs in neutraceutics. It provides most competitive techniques being used in research


Link Download :  httpdownl8AD

Performance and Image Enhancing Drugs and Substances: Issues, Influences and Impacts

Authors : Smith, Aaron; Stavros, Constantino; Stewart, Bob; Westberg, Kate
Edition :
Year : 2018
Description :

In the pursuit of more muscle, enhanced strength, sustained endurance, and idealised physiques, an increasing number of elite athletes, recreational sport enthusiasts, and body conscious gym-users are turning to performance and image-enhancing drugs and substances (PIEDS). In many instances, such use occurs with little regard for the health, social, and economic consequences.　

This book presents a nuanced, evidence-based examination of PIEDS. It provides a classification of PIEDS types, physical impacts, rates of use, user profiles, legal and sporting status, and remedial program interventions, covering both elite and recreational use.

It offers the perfect guide to assist students, government policy makers, and sport managers in understanding the complex issues surrounding PIEDS consumption. It is also an invaluable reference for elite, community, and recreational athletes when making informed choices about safe and efficacious consumption of PIEDS.

• 1 Apply, ingest, inject and regret: introduction to performance and image enhancing substances
• 2 Power, pleasure, fat and fit: dietary and nutritional supplements as PIEDS
• 3 Use, abuse, patterns and profiles: scale and scope of PIEDS use in sport
• 4 Channels, choices, causes and codes: the impact of culture, values and ethnicity
• 5 Thoughts, functions, brains and boosters: cognitive enhancers as PIEDS 6 Protein, prohormones, steroids and stimulants: performance and image enhancing drugs and substances typology of classes7 Givens, gaps, confidences and cautions: conclusion

Link Download :  httplibgeEB8B

Drugs in Sport

Authors : Chester, Neil; Mottram, David R
Edition :  7
Year : 2018

Description Drugs in Sportis the most comprehensive and accurate text on the emotive, complex and critical subject of doping and illegal performance enhancement in sport. Thoroughly updated in light of the latest World Anti-Doping Code and taking into account the latest regulations, methods and landmark cases, this seventh edition explores the science behind drug-use in sport, as well as its ethical, social, political and administrative context.

Introducing an increased focus on inadvertent doping, athlete-support personnel as key stakeholders in the doping process, societal drug-use, and the role of national governing bodies and anti-doping organisations, the book covers key topics including:

• an assessment of the prevalence of drug-taking in sport
• the latest doping control regulations stipulated by the World Anti-Doping Agency (WADA)
• the science and side effects of each major class of drug used in sport
• cutting-edge issues such as gene doping and biological passports
• issues surrounding legal substances and ergogenic aids in supplements
• medical and pharmaceutical services at major sporting events

Accessibly written, and supported throughout with illustrative case studies and data,Drugs in Sportprovides a crucial and objective resource for students and researchers, athletes, sports scientists, coaches and athlete-support staff, journalists, sports administrators and policymakers, alike
Link Download :  http:downDAD

Drugs in use : case studies for pharmacists and prescribers

Authors : Dodds, Linda J.
Year : 2015
Edition : 5
Description :

Drugs in Use: Case Studies for Pharmacists and Prescribers helps you to bridge the gap between theoretical knowledge about medicines and the practical application to your patients. With an ever increasing shift of focus from theory to practice this book promotes evidence-based medicine and illustrates how you can optimise drug therapy in response to the needs of your individual patients. It will prove a valuable resource to pharmacists and prescribers. The cases have been updated to reflect recent changes in medicines use and this new edition boasts: New evidence concerning optimal care; Additional coverage of situations with difficulties in treatment optimisation; Significant focus on major advances in therapeutics; Self study questions and answers within each case. With self study questions and answers to accompany each case, you will find this a useful resource throughout your career. As a student, it will assist your studies and as a practicing pharmacist or prescriber in hospital or community it will aid your continuing professional development.


Hypertension
Ischaemic Heart Disease
Myocardial Infarction
Cardiac Failure
Stroke
Type I Diabetes in Childhood
Type II Diabetes Mellitus
Acute Renal Failure
Chronic Renal Failure Managed By Automated Peritoneal Dialysis
Renal Transplantation
Asthma
Chronic Obstructive Pulmonary Disease
Peptic Ulcer
Crohn's Disease
Alcoholic Liver Disease
Rheumatoid Arthritis
Osteoporosis
Epilepsy
Parkinson's Disease
Depression
Schizophrenia
Dementia
Substance Misuse
Human Immunodeficiency (HIV) Disease: Opportunistic Infections and Antiretroviral Therapy
Oncology
Symptom Control in Palliative Care
Eczema
Psoriasis
Anticoagulant Therapy
Colorectal Surgery
Cholecystectomy
Medicines Management
Managing Medicine Risk.


Link Download :  httpdownEA8C

The War on People who Use Drugs: The Harms of Sweden’s Aim for a Drug-Free Society

Authors : Jay Levy
Edition : 1
Year : 2018
Description :

This book explores the outcomes of Sweden’s aim to create a ‘drug-free society’ on the lived realities, health, and welfare of people who use drugs, and on the dynamics of Swedish drug use. Drawing on a wealth of empirical data, including extensive interview testimony and participant observation from years of fieldwork conducted in Sweden, the book debunks the widely-believed myth that Sweden is a progressive, liberal, inclusive state. In contrast to its liberal reputation, Sweden has criminalised the use of drugs and allows for compulsory treatment for those with drug dependencies. The work argues that Swedish law and policy cannot be demonstrated to have decreased drug use as intended, with the law used instead as a means with which to displace people who use drugs from public spaces in Sweden’s cities. And where the law has failed in its ambition to decrease drug use, Swedish law and policy have increased and exacerbated the problems, dangers, and harms that can be associated with it. People who use drugs in Sweden experience considerable and endemic difficulties with health, violence, abuse, and social exclusion, stigma, and discrimination as a result of Sweden’s drug laws, policies, and discourses.


Link Download :  httpibgen8DEC

Essentials of Medical Pharmacology

Authors : K. D. Tripathi
Edition : 8
Year : 2018
Description :

Revised and updated chapters including new drugs and latest treatment guidelines.
Wide range of topics from basic pharmacological concepts to practical therapeutics.
A new chapter on 'Nitric Oxide and Vasoactive Peptide Signal Molecules’; has been added along with novel drugs that act by modifying action/turnover of these molecules.
Priority has been accorded to drugs that are marked in India and their leading brand names are mentioned along with dosage forms.
List of abbreviations provided in the beginning of the book.
All recently released drugs are included.
Eye catching drug classification charts which help create pictorial memory.
Several new figures, charts, tables and highlight boxes have been added.
Focus on 'evidence-based medicine' by extensive reference to credible studies and endpoint trials.
India-specific information on diseases, drugs and treatment guidelines, particularly for TB, leprosy, Hiv-Aids, malaria, kala-azar, etc.
Therapeutic recommendations from eminent professional bodies and organizations.
The ‘Problem Directed Study’ at the end of most chapters provides an exercise in therapeutic decision making.
Includes Appendices on Solution to Problem Directed Study; Prescribing in Pregnancy; Drugs in Breastfeeding; and Drugs and Fixed Dose Combinations Banned in India.
A brief list of useful references for further reading is provided at the end of the book.


Link Download :  httplibgDCBE

Pharmocracy: Value, Politics, and Knowledge in Global Biomedicine

Authors : Kaushik Sunder Rajan
Edition :
Year : 2017
Description :

Continuing his pioneering theoretical explorations into the relationships among biosciences, the market, and political economy, Kaushik Sunder Rajan introduces the concept of pharmocracy to explain the structure and operation of the global hegemony of the multinational pharmaceutical industry. He reveals pharmocracy's logic in two case studies from contemporary India: the controversial introduction of an HPV vaccine in 2010, and the Indian Patent Office's denial of a patent for an anticancer drug in 2006 and ensuing legal battles. In each instance health was appropriated by capital and transformed from an embodied state of well-being into an abstract category made subject to capital's interests. These cases demonstrate the precarious situation in which pharmocracy places democracy, as India's accommodation of global pharmaceutical regulatory frameworks pits the interests of its citizens against those of international capital. Sunder Rajan's insights into this dynamic make clear the high stakes of pharmocracy's intersection with health, politics, and democracy.


Link Download :  http://downEAC

Goodman and Gilman’s The Pharmacological Basis of Therapeutics

Authors : Laurence Brunton, Bjorn Knollmann, Randa Hilal-Dandan
Edition : 13
Year : 2017
Description :

Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, changes in treatment and drug therapy are required. The authors and the publisher of this work have checked with sources believed to be reliable in their efforts to provide information that is complete and generally in accord with the standards accepted at the time of publication. However, in view of the possibility of human error or changes in medical sciences, neither the authors nor the publisher nor any other party who has been involved in the preparation or publication of this work warrants that the information contained herein is in every respect accurate or complete, and they disclaim all responsibility for any errors or omissions or for the results obtained from use of the information contained in this work. Readers are encouraged to confirm the information contained herein with other sources. For example and in particular, readers are advised to check the product information sheet included in the package of each drug they plan to administer to be certain that the information contained in this work is accurate and that changes have not been made in the recommended dose or in the contraindications for administration. This recommendation is of particular importance in connection with new or infrequently used drugs.


Link Download :   http://dowg6004E

Practical pharmacology in rehabilitation : effect of medication on therapy

Authors : Lynette L Carl; Joseph A Gallo; Peter R Johnson
Edition :
Year : 2014
Description :

Practical Pharmacology in Rehabilitation: Effect of Medication on Therapy With Web Resource serves as a textbook for students and a reference book for practicing rehabilitation professionals. Rather than discussing pharmacology as it relates to only a limited segment of rehabilitation professions, this text takes an interdisciplinary approach to the effects of medications on rehabilitation patients and assists rehabilitation professionals in designing patient-specific therapy plans based on coexisting disease states.

Practical Pharmacology in Rehabilitation explains the necessary pharmacology and then focuses on the relationship between medications and the rehabilitation process. It offers a proactive approach to educating the patient and caregiver, monitoring the patient for side effects, and modifying therapy plans to provide the most effective and safe therapy for each patient. Written by a clinical pharmacist, a speech-language pathologist, and a physical therapist and athletic trainer, this unique guide helps readers in these ways:

• Optimize rehabilitation sessions with appropriately timed and dosed administration of medication.

• Understand the effects of medication on cognition and learning necessary for accomplishing the tasks of rehabilitation.

• Identify medication-associated issues affecting the rehabilitation progress, such as dysphagia and problems with muscle function.

• Work with patients, caregivers, staff, and physicians to determine appropriate interventions regarding medication use in patients.

In each chapter, Patient Cases based on the authors’ clinical experiences engage readers in understanding how medications can positively or negatively affect the rehabilitation process. Readers will need to consider the role of various medications, drug interactions, and drug intolerances on speech and language, cognition, and ADL and motor functioning as they apply concepts to determine possible solutions to each case. Throughout the text more than 100 easy-to-use tables provide quick access to information, including potential side effects affecting rehabilitation for common medications used in treatment for many conditions and other possible side effects or considerations. Expanded versions of many of these tables are offered as downloadable PDFs in the accompanying web resource. Those tables provide more complete and in-depth coverage by breaking medications down by class, indications, dosage, and potential side effects or interactions.

Practical Pharmacology in Rehabilitation begins by presenting foundational concepts necessary for understanding clinical disease states and the impact of medications used for treatment on rehabilitation. Chapters that follow are grouped by categories of clinical disease covering psychiatric and cognitive disorders, neurologic and movement disorders, chronic pain syndromes and substance abuse disorders, immune system disorders, and common chronic diseases such as diabetes, cardiac disease, thyroid and parathyroid disease, respiratory diseases, gastrointestinal diseases, and dysphagia.

Each chapter begins with a definition of the condition or special population that it focuses on. Chapters are organized to provide an overview of the pathophysiology, pharmacology, mechanism of action, dosing and monitoring for effects, drug and food interactions, side effects and effects on rehabilitation, and the role of various rehabilitation specialists for each disease state. Summaries conclude each chapter to reinforce the important concepts covered. A glossary is included, and terms are boldfaced in the text to denote their inclusion. A medication index, an index of important terms, and an appendix with information on administering medications using iontophoresis and phonophoresis are also included.

With Practical Pharmacology in Rehabilitation, students in rehabilitation and related health care fields can gain essential knowledge to prevent adverse occurrences and medical complications and work with their patients, caregivers, pharmacists, and physicians to optimize rehabilitation and the return to daily living. For rehabilitation professionals, this essential reference provides an integrated understanding of medication use with nonpharmacologic therapies in rehabilitation patients.

• Introduction to medication monitoring by the rehabilitation specialist --
• Medication effects on the function of the nervous system, muscle function, and cognition --
• Nutrition in the rehabilitation patient --
• Medications to treat psychosis and schizophrenia --
• Medications to treat depression and bipolar disorder --
• Medications to treat delirium, dementia, and Alzheimer's disease --
• Medications to treat anxiety, anxiety disorders, and insomnia --
• Medications to treat seizure disorders --
• Medications to treat spasticity and muscle spasm --
• Medications to treat Parkinson's disease --
• Medications to treat amyotrophic lateral sclerosis, multiple sclerosis, and myasthenia gravis --
• Medications to treat other movement disorders --
• Medications to treat pain --
• Medications to treat chronic pain syndromes --
• Medications to treat substance use disorders --
• Medications to treat common infections in the rehabilitation patient --
• Medications to treat osteoarthritis, gout, and rheumatoid arthritis --
• Medications to treat cancer --
• Medications to treat hypertension, congestive heart failure, and cardiac arrhythmias --
• Medications to treat peripheral artery disease, stroke, and coronary heart disease --
• Medications to treat diabetes --
• Medications to treat respiratory disease --
• Medications to treat thyroid disease, parathyroid disease and osteoporosis --
• Medications to treat gastrointestinal disorders.

Link Download :  http/dowFB371

Preceptor’s handbook for pharmacists

Authors : Lourdes M. Cuéllar and Diane B. Ginsburg
Edition : 3
Year : 2016
Description :

Being a preceptor is hard work. Let ASHP help you become a great leader with the new Preceptor's Handbook for Pharmacists, Third Edition, by Lourdes Cuéllar and Diane Ginsburg. You'll quickly get up to speed on helping students and residents prepare to become effective pharmacists and master patient care.
This updated guide will show you how to:

• Integrate pharmacy students and residents into your practice
• Improve essential communication, teaching, and leadership skills
• Motivate and challenge students, set expectations, and acknowledge and understand generational issues and perspectives
• Establish a professional attitude and bearing in your students
• Develop your students' cultural competency
• Grasp essential teaching skills fundamental to your students' success
• Master the administrative detail of being a pharmacy preceptor
• Understand the skills needed to mentor pharmacy residents and those in fellowships

In the changing world of pharmacy practice, the need for effective preceptors to help prepare both students and residents has never been greater. The Preceptor's Handbook for Pharmacists remains the go-to, authoritative resource for both new and experienced pharmacy preceptors. When you are a preceptor, you create a lifelong impact on young pharmacists.


Table of contents : 

• The Common Core State Standards 
• Language and communication expectations of the standards 
• Analyzing students' ability to meet the expectations of the standards 
• Students with communication disorders 
• Students with autism spectrum disorder 
• Students who are deaf or hard of hearing 
• Students with visual impairment or deaf-blindness 
• Students with specific learning disabilities 
• Students with severe disabilities at the secondary level
• Students who are English-language learners

Link Download :   http://dowc950CCC

Aqueous polymeric coatings for pharmaceutical dosage forms

Authors : Linda A. Felton
Edition : 4
Year : 2017
Description :

Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. 

The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.


Link Download :  http://dowf8FAF68C

Henke’s Med-Math: Dosage Calculation, Preparation & Administration

Authors : Susan Buchholz
Edition : 7
Year : 2011
Description :

Visually appealing and accessible, this best-selling, popular textbook takes the anxiety out of learning dosage calculation and medication administration. The 7th edition has been revised to thoroughly integrate the dimensional analysis method of dosage calculation into every example. 

In every chapter:
Current drug labels bring the calculation exercises into the real world"Critical Thinking” and “Putting It Together” features help students apply their learning through realistic case studies and critical thinking questionsThe new “Research Point” feature introduces evidence-based learning by presenting summaries of current researchFrequent Self-Tests dispersed throughout the chapter and Proficiency Tests at the end of every chapter give students immediate opportunities to test their own knowledge
Plus, more resources are available to students on thePoint, including Journal Articles, Dosage Calculation Quizzes, and Watch and Learn Videos and Concepts in Action Animations on medication preparation and methods of administration.  In addition, a robust Test Generator and PowerPoint presentations are available for instructors.

Henke’s Med-Math provides the practice that “makes perfect” in this important area of nursing care: dosage calculation, preparation, and administration.

This best-selling text features a highly visual, hands-on approach to learning dosage calculations and principles of drug administration. It presents step-by-step approaches to solving problems and includes dosage problems that simulate actual clinical experience. Each chapter includes numerous examples, self-tests, and proficiency tests.


Link Download :   http://dowg449EACC

Pharmaceutical Dosage Forms: Capsules

Authors : Larry L. Augsburger, Stephen W. Hoag
Edition : 1
Year : 2018
Description :

Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Content: 

• Advances in capsule formulation and filling 
• An introduction to two-piece hard capsules and their marketing benefits 
• Hard shell capsules in clinical trials 
• Manufacture of capsule shells 
• Non-gelatin based capsules 
• Hard shell capsule filling machines 
• Instrumented capsule filling machines and filling machine simulators 
• Dry-fill formulation and filling technology 
• Plug formation 
• Modeling powder filling during encapsulation / Ammar Khawam --
• Scaling-up and transfer of hard shell formulations across machine types 
• Modified release delivery systems : extended release capsule platform 
• Analytical testing and evaluation of capsules 
• Rheological aspects of capsule shell excipients and the manufacture of encapsulated formulations 
• Quality-by-design (QBD) for capsule formulation and process development : regulatory science developments, scientific case studies, and future challenges 

Link Download :   http://dowf41E197

Cannabis pharmacy : the practical guide to medical marijuana

Authors : Backes, Michael
Edition : 1
Year : 2014
Description :

In Cannabis Pharmacy, expert Michael Backes presents a comprehensive resource for understanding and using medical marijuana. In this essential guide, Backes provides information on how cannabis works with the body's own system, how best to prepare and administer it, and how to modify and control dosage. He explores 27 of the most popular cannabis varieties and the conditions for which patients have reported effectiveness. He also outlines 29 ailments and illnesses for which doctors commonly recommend medical marijuana, including chronic pain, chemotherapy-induced nausea, migraine, multiple sclerosis, Alzheimer's disease, fibromyalgia, and Parkinson's disease."--Back cover.  
Abstract: The most comprehensive, easy-to-follow book available on treating the symptoms of illness and disease with medical marijuana, written by Michael Backes, a leading expert in the field of medical marijuana research and dispensaries. 


Link Download :   http://downd44D4B

Pharmacology in 7 Days for Medical Students

Authors : Fazal-l-Akbar Danish, Ahmed Ehsan Rabbani
Edition :
Year : 2016
Description :

Pharmacological knowledge among medical students can have a very short 'half life': students often fail not because they have failed to study, but because they have been unable to retain key knowledge and reproduce it in an exam setting. This book takes an alternative route to the conventional approach of comprehensively exploring each individual drug and its features: not only can such an approach overwhelm and make knowledge retention difficult, but the current exam format makes questions structured in this way unlikely anyway. Instead of aiming to be completely comprehensive, it examines drugs systematically by classifications, mechanisms of action, therapeutic uses and side effects, enabling students to gain the distilled, functional grasp of pharmacology that their exams actually demand quickly and clearly.


Link Download :  http://dowf0C478EEEF

FDA’s drug review process and the package label : strategies for writing successful FDA submissions

Authors : Brody, Tom
Edition : 1
Year : 2018
Description :

FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. 


The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. See back cover. 

• 1. Introduction to regulated clinical trials --
• 2. FDA's decision-making process when assessing ambiguous data --
• 3. Food effect studies --
• 4. Dose modification and dose titration --
• 5. Contraindications --
• 6. Animal studies --
• 7. Drug-drug interactions: part one (small molecule drugs) --
• 8. Drug-drug interactions: part two (therapeutic proteins) --
• 9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions --
• 10. Drug class analysis --
• 11. Relatedness --
• 12. Adjudication of clinical data --
• 13. Coding --
• 14. Pooling.

Link Download :  http:bgs01sD92F9C