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The Pfizer Papers features new reports written by WarRoom/DailyClout research volunteers, which are based on the primary source Pfizer clinical trial documents released under court order and on related medical literature. The book shows in high relief that Pfizer’s mRNA COVID-19 vaccine clinical trial was deeply flawed and that the pharmaceutical company knew by November 2020 that its vaccine was neither safe nor effective. The reports detail vaccine-induced harms throughout the human body, including to the reproductive system; show that women suffer vaccine-related adverse events at a 3:1 ratio; expose that vaccine-induced myocarditis is not rare, mild, or transient; and, shockingly, demonstrate that the mRNA vaccines have created a new category of multi-system, multi-organ disease, which is being called “CoVax Disease.” Despite the fact that Pfizer committed in its own clinical trial protocol to follow the placebo arm of its trial for twenty-four months, Pfizer vaccinated approximately 95 percent of placebo recipients by March 2021, thus eliminating the trial’s control group and making it impossible for comparative safety determinations to be made. Just as importantly, The Pfizer Papers makes it clear that the US Food and Drug Administration knew about the shortfalls of Pfizer’s clinical trial as well as the harms caused by the company’s mRNA COVID vaccine product, thus highlighting the FDA’s abject failure to fulfill its mission to “[protect] the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.” The Pfizer Papers offers an in-depth look at how Big Pharma, the US government, and healthcare entities stand protected behind the broad legal immunity provided by the Public Readiness and Emergency Preparedness Act (PREP Act) when creating, prescribing, and administering vaccines; and, under that shield of protection, do what is best for their bottom lines rather than for the health and well-being of Americans.
The "Purple Book" is an authoritative, user-friendly guide to almost everything related to immunization. Easy to navigate yet replete with up-to-date information, this handy resource contains practical advice and background on vaccine program infrastructure, standards and regulations, business aspects of vaccine practice, general recommendations, schedules, special circumstances, and how to address the concerns. Specific information about vaccine-preventable diseases, the rationale for vaccine use, and available products is included. The new edition is replete with useful information about COVID-19 vaccines as well as updates on other new vaccines and routine recommendations for 2022. The book is targeted to pediatricians, family practitioners, internists, obstetricians, residents, medical students, nurse practitioners, and physician assistants. The Purple Book is one-stop shopping for everything you need to know in using vaccines to prevent disease and preserve health.
The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.
This volume focuses on the most recent trends for greening analytical activities beginning with an introduction to green analytical chemistry followed by a discussion of green analytical chemistry metrics and life-cycle assessment approach to analytical method development. The chapters discuss two main topics; first is the most recent techniques for greening sample pretreatment steps, and second is modern trends for tailoring analytical techniques and instrumentation to implement the green analytical chemistry concept. The role of different kinds of green solvents, such as ionic liquids, supercritical fluids, deep eutectic solvents, bio-based solvents, and surfactants, as well as nanomaterials and green sorption materials in greening sample extraction steps is also a focus of this book. Furthermore, different approaches for greening chromatography as a key analytical technique are discussed. The applications of nanomaterials in analytical procedures are deeply reviewed, and miniaturization of spectrometers is also discussed as a recently evolved approach for efficient green on-site analysis. This book will appeal to a wide readership of academic and industrial researchers in different fields. It can be used in the classroom for undergraduate and postgraduate students focusing on the development of new analytical procedures for organic and inorganic compounds determination in different kinds of samples characterized by complex matrices composition. The book will also be useful for researchers that are interested in both chemical analysis and environment protection.
[This book is an] organized 'formulary' written for those who are considering a specific field - 'drug reps', as they are known in the industry.-Introd.
In order for you to make a difference to new pharmacists, you must remain challenged and energized by your role as preceptor. ASHP’s Preceptor’s Handbook for Pharmacists, second edition, in a completely revised format, gives new and experienced preceptors, residents, and pharmacy directors the practical advice needed to start new pharmacists on the path to success.In eleven, no-nonsense chapters, you will learn what it takes to be an effective preceptor, mentor, and career advisor.Inside you will learn how to: Fit precepting responsibilities into your schedule Guide yourself and your site through the new ACPE guidelines Ask leading questions Calm students’ fears and worries Give constructive feedback Use the latest assessment tools Promote self-directed learning Develop effective goals and objectives for your student And much more! The second edition features new tips, updated content, and newly organized information so that you can find the information you need quickly. It was also written with terminology that complies with ACPE standards. “Pearls” are highlighted so that you can pick up the book anytime you need inspiration.
Emotional, behavioral, and neuropsychiatric conditions are common in individuals with intellectual disabilities (IDs), most notably epilepsy, aggression, self-injurious behaviors, and bipolar and other mood disorders. Despite the prevalence of such problems, there is a scarcity in the literature of reliable information on medical treatments for those with IDs. A Practitioner's Guide to Prescribing Antiepileptics and Mood Stabilizers for Adults with Intellectual Disabilities provides a detailed framework for prescribing for this challenging population. Featuring the most up-to-date information on factors that inform prescribing, the Guide addresses basic issues and controversies (e.g., the rift between evidence-based and personalized medicine) in treating adults with cognitive deficits. Clients' specific needs are emphasized in developing appropriate and effective pharmacological intervention for improved outcomes and quality of life. Drugs discussed in the Guide include carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, lithium, lorazepam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, primidone, rufinamide, tiagabine, topiramate, valproate, and zonisamide. For each of these compounds, the guidelines cover: Indications for use; relative and absolute contraindications. Assessment during treatment; therapeutic drug monitoring; warning signs and symptoms for caretakers. Dosage: administration; initial and maximum recommended dosage; modifications associated with drug-drug interactions, personal characteristics, and (where appropriate) genetic variations. Adverse drug reactions: common, relatively uncommon, and potentially lethal, plus risk of metabolic syndrome. Guidelines for discontinuation. References, tables, and drug utilization reviews. A Practitioner's Guide to Prescribing Antiepileptics and Mood Stabilizers for Adults with Intellectual Disabilities is an indispensable decision-making reference for psychiatrists, neuropsychologists, psychopharmacologists, neurologists, internists, and clinical psychologists.