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Attachment: Product Information: Atazanavir
Attachment: Product Information: Atazanavir

... Australian Pty. Ltd. PM-2012-01034-3-2 Final 21 October 2013. This Product Information was approved at the time this AusPAR was published. Cmin ng/mL Geometric Mean (CV%) ...
Accelerating antimalarial drug discovery through repositioning Holly
Accelerating antimalarial drug discovery through repositioning Holly

... the requirements for a Degree of Doctor of Philosophy, is a presentation of my own research work. Wherever contributions of others are involved, every effort is made to indicate this clearly with due reference to the literature and acknowledgement of collaborative research and discussions. The conte ...
Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone
Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone

Update on the Pharmacodynamics and
Update on the Pharmacodynamics and

... not with adequate safety. serum ...
blueprint medicines corporation - corporate
blueprint medicines corporation - corporate

... Blueprint Medicines Corporation (the Company), a Delaware corporation formed on October 14, 2008, is a biopharmaceutical company focused on improving the lives of patients with genomically defined diseases driven by abnormal kinase activation. The Company’s approach is to systematically and reproduc ...
Important Drug Information
Important Drug Information

... toxic effect, mucositis. However, there are some regimens which divide the dose over three successive days (20-25 mg/m2 or 0.4-0.8 mg/kg). It is thought that this regimen has greater effectiveness although at a cost of higher toxicity. Administration of doxorubicin in a weekly regimen has been shown ...
Potential Drug Interactions - edoc
Potential Drug Interactions - edoc

... interaction alerts. The median frequency of drug interaction alerts increased from 0.5 to 40 to 76 depending on the settings of the 15 community pharmacies’ computer systems to flag only severe (N=4), severe and moderate (N=6) or severe, moderate and minor (N=5) potential drug interactions. Because ...
Plasma Pharmacokinetics of Adriamycin and
Plasma Pharmacokinetics of Adriamycin and

... sampling for several days for adequate characterization, (b) Metabolism of Adriamycin requires assay techniques which sep arate parent drug and metabolites and allow sensitive quantitation of Adriamycin and other metabolites of interest. The pres ence of active metabolites can obscure the evaluation ...
CYCLODEXTRINS
CYCLODEXTRINS

... cavity and a hydrophilic outer surface. Due to the chair conformation of the glucopyranose units, the cyclodextrins are shaped like a truncated cone rather than perfect cylinders. The hydroxyl functions are orientated to the cone exterior with the primary hydroxyl groups of the sugar residues at the ...
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... The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity suffic ...
Application of Hepatocytes for In Vitro Uptake Studies
Application of Hepatocytes for In Vitro Uptake Studies

... Adapted from Zamek-Glisczynski et al., ITC Workshop, Clin Pharm Ther 92(5): 2012 ...
Clinical relevance of the small intestine as an organ of
Clinical relevance of the small intestine as an organ of

... some of these diet-derived xenobiotics may be capable of modulating drug metabolism in a manner similar to therapeutic agents [18,191. Therefore, inhibition of drug metabolism by dietary substances could lead to increased concentrations of the target drug and the potential for an exaggerated pharmac ...
Forced Degradation of Ibuprofen in Bulk Drug and Tablets
Forced Degradation of Ibuprofen in Bulk Drug and Tablets

... analyte unequivocally in the presence of expected components, should be demonstrated to qualify the method as stability indicating (3). Subjecting the drug substance and drug product samples to forced degradation (stress testing) is necessary to generate degradation products that are used to demonst ...
Aloe vera: Plant of Immortality - International Journal of Pharma
Aloe vera: Plant of Immortality - International Journal of Pharma

International Financial Reporting Standards (IFRS) Issues and solutions for the
International Financial Reporting Standards (IFRS) Issues and solutions for the

... Capitalisation of internal development costs when regulatory approval has been obtained in a similar market - scenario 1 Capitalisation of internal development costs when regulatory approval has been obtained in a similar market - scenario 2 Capitalisation of development costs for generics Accountin ...
product monograph
product monograph

an-update-of-taste-m.. - Scholars Research Library
an-update-of-taste-m.. - Scholars Research Library

... coating has to be optimized. If purpose of coating is taste masking, it may be simple taste panel to determine the proper coating level. Thick coating can cause problems both in terms of size and cost apart from being problematic in getting the desired release profile of the drug. However, by coordi ...
pharmacy technical assistance - Ministère de l`Éducation et de l
pharmacy technical assistance - Ministère de l`Éducation et de l

... A situational competency describes the situation in which students are placed to acquire learning, and allows for actions and results to vary from one student to another. It consists of the following features: The statement of the competency is the result of the job analysis, the orientations and ge ...
In silico methods in prediction of drug metabolism, mass
In silico methods in prediction of drug metabolism, mass

... are available to speed up and assist with the interpretation of analytical data. In the present thesis, current in silico systems were evaluated for their usefulness within accurate mass-based toxicological drug screening. Different software tools were employed to predict drug metabolism, mass fragm ...
NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen
NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen

... Programs (NCPDP). It may be freely redistributed in its entirety provided that this copyright notice is not removed. It may not be sold for profit or used in commercial documents without the written permission of the copyright holders. This document is provided ―as is‖ without any express or implied ...
Acetylsalicylic acid - Wiley Online Library
Acetylsalicylic acid - Wiley Online Library

... tition coefficients. They used metoprolol as the reference compound, since 95% of this drug is known to be absorbed from the GI tract (logPmetoprolol = 1.72). Drugs with estimated logP values of at least 1.72 were classified as high permeability drugs on this basis. As logPASA is considerably lower ...
Nitrofurantoin revisited: a systematic review and meta
Nitrofurantoin revisited: a systematic review and meta

Dapagliflozin (as propanediol monohydrate) / Metformin hydrochloride
Dapagliflozin (as propanediol monohydrate) / Metformin hydrochloride

PDF 838 kb - Patented Medicine Prices Review Board
PDF 838 kb - Patented Medicine Prices Review Board

... of Dalhousie University for her insightful comments and critical review of the draft report. ...
Key Considerations in Capsule Filling
Key Considerations in Capsule Filling

... mentioned forms. It is also possible to fill liquids, provided that the material of the capsule (generally gelatin, although there are other alternatives) is not soluble in the solvent used in the formulation. Due to the need for a plasticizer in the capsule shell formulation, conventional hard gela ...
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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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