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SFINX—a drug-drug interaction database designed for
SFINX—a drug-drug interaction database designed for

Pharmacy Services White Papers
Pharmacy Services White Papers

... dose (MTD) is identified (1-3), or calculated exposure limits based on animal toxicology, or a pre-established biological endpoint has been reached. The latter is often an estimation of the eventual effect in the targeted patient population. Such a study is then typically followed by a multiple-dose ...
challenges in adc development
challenges in adc development

...  Consisted of a humanised IgG4 mAb directed against CD33 (a surface antigen present in 85–90% of AML) linked to a calicheamicin cytotoxin  Licensed as a monotherapy in patients over 60 years old with acute myelogenous leukemia (AML) who were not candidates for cytotoxic chemotherapy  In 2010, res ...
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Introduction to Pharmacology
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... and protein synthesis to occur before becoming manifest • Another example is the effects of warfarin on blood clotting-decreased synthesis of clotting factors occurs immediately but existing factors are somewhat stable ...
off-label use - Moodle Lille 2
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... Two Randomized, Double Masked, Active Controlled, multicenter phase 3 studies. View1: n= 1217, in USA and Canada View2: n= 1240, in Europe, Asia Pacific, Japan and Latin ...
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... ingredient is involved, use of same or a chemically similar agent places the individual at risk for harm when the same or chemically similar agent is used. The subsequent reaction may be the same as the original reaction or a more exaggerated response may be seen, potentially placing the individual ...
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... folklore and traditional medicine. 2~ Of the plant-derived anticancer drugs in clinical use, the best known are the so-called vinca alkaloids, vinblastine and vincristine, which are isolated from the Madagascar periwinkle, Catharanthus roseus. C. roseus was used by various cultures for the treatment ...
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... during pregnancy. The most common birth defect reported to GSK was congenital heart defects, though other defects including cleft lip and palate, intrauterine death, still birth, and severe malformations were also reported. In addition, at least 4 peer reviewed studies have been published since 2004 ...
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... and parameters such as drug uniformity, drug entrapment efficiency (DEE) and in-vitro drug release were studied. The results clearly indicated that retardation of drug release for 4 h was achieved by the oil hydrophobic diffusional barrier, especially in the presence of the compact network of algina ...
02/20/2009 - Medical University of South Carolina
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... object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is ...
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... Placental barrier. Placental membranes are lipid and allow free passage of lipophilic drug, while restricting hydrophilic drugs. The placental P-gp also serves to limit foetal exposure to maternally administered drugs. However restricted amounts of nonlipid soluble drugs, when present in high conce ...
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... mirrors of each other. On the one hand, if the drug were made explicitly legal, organized crime might be replaced by legitimate manufacturers who were initially unwilling to produce and market a substance not yet dealt with in the formal regulatory system. On the other hand, it is also possible that ...
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... toxic effects. May be due to the accumulation of the drug in the body r/t decreased renal function • Teratogenic Effects: Drug induced birth defects which follow drug therapy in pregnant women. ...
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... which could cause toxicity • if albumin concentration is decreased (liver failure or nephrotic syndrome), dose of highly bound drug must be lowered to avoid toxicity • competition for binding sites between drugs and endogenous substrates can result in interactions and toxicity • significant drug int ...
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... What needs to be done and when? • First Dose in Man is a key Milestone for a new Pharmaceutical - provides human safety/tolerability and PK data - can provide efficacy, biomarker activity or proof of principle - can be in patients or volunteers ...
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... initiatives and networks for collaboration and cooperation in accordance with WHO principles and guidelines, and increase support for and recognition of the significant role of the International Conference of Drug Regulatory Authorities in promoting the exchange of information and collaborative appr ...
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Topic D HL past paper questions 2011 (M10 – TZ2) Drugs can be
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... 27. (M08) Some medicines prescribed by doctors are classified as depressants. These depress the central nervous system. One depressant not prescribed by doctors but widely used in some societies is ethanol. (a) Describe two long-term effects of consuming large quantities of ethanol on the human body ...
AAPM Report No 121
AAPM Report No 121

... responsibility and ultimately the liability for off-label use often rest with the prescribing physician, the medical physicist and others may also be responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is ...
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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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