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Drug-Coated Balloons for Coronary Artery Disease
Drug-Coated Balloons for Coronary Artery Disease

... the registry will undergo angiographic follow-up at 6 or 9 months to assess in-stent and in-segment late loss and binary restenosis. FUTURE PER SPECTIVE Several small clinical studies using DCB have shown encouraging results for the application of this technology in the coronary territory. However, ...
l[SCHEDULE Y (See rules l22A, l22B, 122D, 122DA, 122DAA and
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IN VITRO RELEASE OF SODIUM DICLOFENAC FROM POLOXAMER 188 MODIFIED
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... overnight and subsequently the images were recorded at 300 kV. In vitro drug release studies The in vitro drug release behaviour of pure diclofenac sodium and the optimal clay drug composite was carried out using dialysis bag method at a constant temperature bath [6]. Buffer solution of pH 1.2 (simu ...
Fluvoxamine as a cause of stimulation, mania and
Fluvoxamine as a cause of stimulation, mania and

capecitabine - Medicines and Healthcare products Regulatory Agency
capecitabine - Medicines and Healthcare products Regulatory Agency

... Reliance 150 mg and 500 mg film-coated tablets were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use Capecitabine Reliance 150 mg and 500 mg film-coated tablets. These products will be referred to as Capeci ...
APRI 7149$
APRI 7149$

... is one of the primary precursors used in the illicit manufacture of methamphetamine and methcathinone. As such, it contributes to the public health risk associated with these In recent years, at least 26 U.S. states have placed substances. additional controls on ephedrine, and additional states have ...
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Potential Herb-Drug Interactions for Commonly

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Introduction to Pharmacokinetics and Pharmacodynamics

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Herb-drug interactions
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Pharmaceutical Innovations and Market Dynamics: Tracking Effects

... 1996. We have chosen this market segment and time period for several reasons, all relating to the high likelihood of there being substantial challenges here in tracking price changes.' First, several very successful new products have been introduced in the antidepressant drug class, with well-known ...
rencana program dan kegiatan pembelajaran
rencana program dan kegiatan pembelajaran

... The evaluation of drugs for the formulary includes the review of generic drugs and other therapeutic equivalents so the most cost-effective formulary for the hospital and primary care clinic can be established. The evaluation process should include review of the primary drug literature (especially r ...
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22 - 25 May 2016 Programme of Abstracts

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physicochemical properties and the discovery of - Beilstein
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... compounds with potent in vitro activity. This focus was completely understandable given the difficulty of discovering a drug lead with potent in vitro activity in the decade of the 1980’s. Peptide scaffold based combinatorial libraries did indeed generate potent in vitro active compounds in the new ...
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... In April 2016, preclinical data were presented for CA-4948, the oral IRAK4 inhibitor at the Annual AACR meeting in New Orleans. The presentations outlined CA-4948’s detailed pharmacologic and biologic profile as well as data on its metabolism, pharmacokinetics properties and in vitro toxicity profil ...
MELATONIN for treatment of sleep onset insomnia and
MELATONIN for treatment of sleep onset insomnia and

... cerebral palsy, attention deficit hyperactivity disorder, autism, and learning difficulties. It is also sometimes used before MRI, CT, or EEG investigations. Little is known about its long-term effects in children, and there is uncertainty as to the effect on other circadian rhythms including endocr ...
AusPAR Dexamethasone - Therapeutic Goods Administration
AusPAR Dexamethasone - Therapeutic Goods Administration

... corrected visual acuity (BCVA) [area under the curve (AUC)] change from baseline) and this difference was small (1 to 2 letters over the 3 year study) and of questionable clinical significance (the minimal clinically important difference used in the sample size calculation was a 4 letter difference ...
Gene therapy clinical trials: what about the environment?
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... In all jurisdictions, gene therapy clinical trials are within the scope of existing regulatory systems that govern human clinical trials or biomedical research. These regulations in the first place aim at the safety of the human subject in the studies. The product-based approach is most apparent in ...
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... • Midazolam (for seizures): 5-7mg bolus, then 1-2 mg until controlled. • Let EMS know not to use Diazepam ...
Sustained Release Drug Delivery System Potential
Sustained Release Drug Delivery System Potential

Incentive Salience and the Transition to Addiction
Incentive Salience and the Transition to Addiction

... Most adults have used a potentially addictive drug at least once in their lifetime, if caffeine, alcohol, and nicotine are included in addition to illicit drugs. In some cases, contact with a substance is so frequent and socially accepted that many in society fail to recognize it as a “drug.” Howeve ...
My Prescription Addiction PowerPoint Lecture
My Prescription Addiction PowerPoint Lecture

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How is “safety” - Global Campaign for Microbicides

... Contraceptive effectiveness-Safety endpoints--systemic and local genital safety are assessed Behavioral endpoints--condom use dynamics, changes in ...
Yanyan Cui, Mona I. Churchwell, Letha H. Couch, Daniel
Yanyan Cui, Mona I. Churchwell, Letha H. Couch, Daniel

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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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