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Phospholipid Complex Technique for Superior Bioavailability of
Phospholipid Complex Technique for Superior Bioavailability of

... complexed actives are safer than its original form1 and can even serve as a better targeting agents to deliver these encapsulated agents at specific sites there by proving promising candidates in various medical fields for improving health aspects. This technique can be applied for both herbal and c ...
Project: Abbott Course Title: REDUCTIL Module title/ID: Competition
Project: Abbott Course Title: REDUCTIL Module title/ID: Competition

... uncomfortable history of anti-obesity pharmacotherapy, healthcare professionals will have every reason to be wary of new agents without a good safety record in clinical use. However, it is not only safety considerations that differentiate anti-obesity products. As you learnt in Unit 3, Reductil and ...
Pharmacology for nursing Care 3rd edition
Pharmacology for nursing Care 3rd edition

... (dosage, ½ life, clearance, effects [receptors different in children than adults]) – Clinical trial data base will be established so that informed decisions can be made about trial drugs – Drug companies can now give journal articles about “offlabel” use of drug [use that has not been evaluated by F ...
Systemic enzymes - World Nutrition, Inc.
Systemic enzymes - World Nutrition, Inc.

... Supplementation with systemic enzymes may help the body to more efficiently regulate the metabolism, thereby reducing the physiological effects of aging. Physicians in Europe and Asia have long prescribed enzyme supplements to restore enzyme levels and promote natural healing. Systemic enzymes are f ...
Intro to systemic enzyme therapy
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... Enzymes as proteins are more susceptible to denaturation at higher moisture content. Enzyme powders typically have lower (5-10%) moisture content. However, even with lower moisture content, enzyme powders will lose some of their activity over time, resulting in a loss of up to 20% of activity over a ...
Impurities in New Drug Substances
Impurities in New Drug Substances

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A guide to drug discovery — opinion: Finding the sweet spot: the
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FAIR WORKING CONDITIONS LOGO USER MANUAL FOR
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... program, participating companies who support and adhere to ILO standards are formally approved and have the option to promote their compliance via the use of the FWC logo(s). The objective of this document is to outline the rules and general procedures for the use of FWC logos. FWC logos are the int ...
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Using Arrays to Quickly Perform Fuzzy Merge Look-ups: Case Studies in Efficiency

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Predictability of Idiosyncratic Drug Toxicity Risk for Carboxylic Acid
Predictability of Idiosyncratic Drug Toxicity Risk for Carboxylic Acid

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Atgard® C - Boehringer Ingelheim Vetmedica
Atgard® C - Boehringer Ingelheim Vetmedica

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Combination Homeopathy Products in the Retail Setting
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... great majority of homeopathic drugs are OTC in commonly available potencies. The FDA’s Compliance Policy Guide 7132.15 (also known as 400.400) describes the conditions under which homeopathic drugs may be marketed, including labeling requirements. For homeopathic medications, the strength is not lab ...
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FREQUENTLY ASKED QUESTIONS
FREQUENTLY ASKED QUESTIONS

... production capacity for Authorized Generics reduces the possibility of marketplace supply interruptions. Consumers also have the identical product experiences with Authorized Generics as they do with brand products in areas such as taste, color, mouth feel and shape. And, by being an additional gene ...
Ophthalmic Preparations - triphasepharmasolutions.com
Ophthalmic Preparations - triphasepharmasolutions.com

... The human eye can be generally divided into the anterior and the posterior segments. The anterior segment includes the cornea, conjunctiva, iris, ciliary body, aqueous humor and lens while the posterior segment comprises sclera, choroid, retina and vitreous humor (Figure 1). The cornea, the outermos ...
chapter 1 - New Age International
chapter 1 - New Age International

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Statement on the use of EFV in children less than 3 years of age
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... 12 June 2013 Statement on the use of Efavirenz in children less than 3 years of age On 02 May 2013, the US Food and Drug Administration (FDA) expanded the indication for efavirenz (EFV) to include paediatric patients at least three months old and weighing at least 3.5 kg. Historically efavirenz has ...
Rise in LSD use among Regular Psychostimulant Users: Why the
Rise in LSD use among Regular Psychostimulant Users: Why the

... detections and hallucinogen seizures and arrests since the 2005-2006 period. Thus it may be the case that hallucinogens are becoming more available or at least more prevalent and given that NSW accounts for most of the seizures by number this may explain why NSW has seen an increase in recent usage. ...
Optimizing antifungal choice and administration
Optimizing antifungal choice and administration

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CURRENT STATUS OF DESIGNER DRUGS

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Research Protocol - Newcastle University
Research Protocol - Newcastle University

... (ONS) reported 56 deaths in England and Wales in 2012 where an NPS was mentioned on the death certificate following a drug-related death, almost double the figure for 2011.27 ONS also reported increases in deaths related to specific newer recreational drugs including cathinones (from 6 to 18) and pa ...
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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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