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Antibiotic Residue Avoidance Strategy
Antibiotic Residue Avoidance Strategy

... Intramuscular (IM) injections not only increase soreness compared to subcutaneous (SQ) injections, many of the products given IM cause significant muscle damage which subsequently causes a significant amount of expensive carcass trim. Knots or blemishes from SQ injections are much easier to find, ex ...
Article 07-10: Carcinogenicity of Lipid-lowering Drugs
Article 07-10: Carcinogenicity of Lipid-lowering Drugs

... cholesterol-lowering drugs cause cancer in humans. In the meantime, the results of experiments in animals and humans suggest that lipid-lowering drug treatment, especially with the fibrates and statins, should be avoided except in patients at high short-term risk of coronary heart disease. THESE AUT ...
In Pursuit of Science-based Regulation: FDA, FTC, and the
In Pursuit of Science-based Regulation: FDA, FTC, and the

... “It seems reasonable that if a little bit of something is good for you, then more should be better for you. It's not true. Supplementation with extra vitamins or micronutrients doesn't really benefit you if you don't have a deficiency.”27 A science-based approach to medicine has consistently shown t ...
Why do we need Pharmacovigilance?
Why do we need Pharmacovigilance?

... PV is the science and activities dealing with the detection, assessment, understanding and prevention of adverse effects of drugs. It has been widened to include biological products, herbals, traditional and complementary medicines. ...
DEPARTMENT  OF  HEALTH  AND  l3IT.IMm ...
DEPARTMENT OF HEALTH AND l3IT.IMm ...

... use, the notification statesthat the produvt is for use as a dietary supplement consuming not more than one bottle three times daily, The notification also statesthat the product is not recommendedfor use by young,bhildren or by pregnant or lactating women and that the product label will provide the ...
The Post-Amarin Age and Its Potential Effect on Off
The Post-Amarin Age and Its Potential Effect on Off

... approved indication from FDA in 2012, Amarin submitted a supplemental new drug application for a second indication in 2013, and anticipated a timely approval for treating patients with persistently high triglyceride levels from 200 to 499 mg/dL who have already received statin therapy. Amarin believ ...
Revised: May 2013 AN: 01690/2012 SUMMARY OF PRODUCT
Revised: May 2013 AN: 01690/2012 SUMMARY OF PRODUCT

... veterinary medicinal product to animals Wash hands after use. In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician. Pregnant women should take special care to avoid accidental oral exposure because angiotensin converting enz ...
citeline Pharma r&d annual review 2015
citeline Pharma r&d annual review 2015

... The most keenly-tracked data from this graph is always the numbers of drugs which are in the three stages of clinical development. Our information here is always extremely robust, by dint of our collaboration with the leading worldwide source of clinical trials intelligence, Citeline’s Trialtrove. ...
Document
Document

... would be prudent to carefully monitor the drug therapy of women taking tamoxifen • In the future may need to test women on tamoxifen for the CYP2D6 polymorphism, however some way we should be testing all women who are to be treated with tamoxifen now… – May help identify women who should be on an al ...
Questions and answers EMA-FDA GCP initiative
Questions and answers EMA-FDA GCP initiative

... inspection processes and to fill in those gaps—with the broader aim of moving from “confidence building” to “confidence in,” with mutual acceptance of inspectional findings in the near future. The initiative will be expanding to sites outside the US and EU and will focus the joint inspections on spo ...
Why is it important to consider the route of
Why is it important to consider the route of

Discussion Continuum 1: Who pays to develop drugs? Introduction
Discussion Continuum 1: Who pays to develop drugs? Introduction

... Marketing new drugs When a new drug has been developed and tested, a dossier is submitted for approval to regulatory agencies in each country or geographical area (the European Medical Evaluation Agency, EMEA, or the Food and Drug Administration Agency, FDA, for example). These agencies analyse the ...
Drugs and Medical Devices in Research
Drugs and Medical Devices in Research

... A substance (other than food) intended to affect the structure or any function of the body; or A substance intended for use as a component of a medicine but not a device or a component, part, or accessory of a device. Note: Biological products (e.g., vaccine, virus, or blood) are included within thi ...
Statement by the American Medical women’s
Statement by the American Medical women’s

... disparities in risk factor evaluation and treatment that occur in women, even for potentially serious risk factors or life-changing medical problems. Since efforts that increase the availability of options for treatment of these risk factors and conditions are crucial to improving women’s health, we ...
Slide 1
Slide 1

... There are many ways in which to classify drugs. Some of the more common are by; • Chemical name or properties • Route of administration • Therapeutic effects • The biological system affected. • For example, N-acetyl-p-aminophenol is paracetamol of brand name calpol which is an analgesic. ...
CNS Depressants GABA Receptor Complex Barbiturates
CNS Depressants GABA Receptor Complex Barbiturates

PHARMACOLOGY Pharmacology is an experimental science
PHARMACOLOGY Pharmacology is an experimental science

... Pharmacology is an experimental science dealing with properties of drugs and their effects on living systems. If the substances have medical properties, they are considered pharmaceuticals. Drugs may be used to improve health and quality of life, to treat and prevent diseases, or as a research tool ...
Statement bv the American Medical Women’s
Statement bv the American Medical Women’s

... disparities in risk factor evaluation and treatment that occur in women, even for potentially serious risk factors or life-changing medical problems. Since efforts that increase the availability of options for treatment of these risk factors and conditions are crucial to improving women’s health, we ...
Doxazosin NM Pharma 4 mg prolonged
Doxazosin NM Pharma 4 mg prolonged

The process of evaluating and regulating a new durg
The process of evaluating and regulating a new durg

... studies of the first 3 phases. As discussed, phase 4 trials might detect previously unidentified side effects. Conversely, new indications for the drug also might be discovered. Other types of trials involved in phase 4 are geriatric use trials, cost-effectiveness trials, comparative trials, and qua ...
Degradation Studies
Degradation Studies

... Studies under accelerated conditions may provide useful support data for establishing the expiration date, provide product stability information or future product development (e.g., preliminary assessment of proposed manufacturing changes such as change in formulation, scale-up), assist in validatio ...
Maximizing the Value of Early Phase Drug Development
Maximizing the Value of Early Phase Drug Development

File
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... What factors would he need to control in his experiment? __the one not getting product X is his main control or baseline. The things that are constant are that he has to use the same amount of product X throughout the whole experiment. Same type of roses, all grown in same area, make sure they recei ...
Express Scripts Drug Information & Wellness Center Drug Information Updates
Express Scripts Drug Information & Wellness Center Drug Information Updates

... Other NSAIDs are thought to be excreted as the active compound. Sulindac is excreted in the urine primarily as the inactive form which may possibly affect renal function less than other NSAIDs but renal adverse experiences have been reported.3 A prospective randomized crossover trial published in 19 ...
infomedbaseproducts
infomedbaseproducts

... • SFINX contains information on more than 17.000 drug interactions (5/2014) - one of the most comprehensive drug interaction databases in the market • SFINX gives a warning on the potential clinical problem with a specific drug interaction taking into account the formulation of the drug • SFINX prov ...
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Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original ""innovator"" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarxio.
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