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Reference product

Analytical characterization of recombinant hCG and comparative studies with reference product

Analytical characterization of recombinant hCG and comparative studies with reference product

... innovator product and biosimilar product, it does not necessarily mean that the quality attributes of the biosimilar and innovator product are identical but they should be highly similar and that the ...

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FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double blind study, and its open label extension

FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double blind study, and its open label extension

... the reference product (RP), is a biological disease- modifying anti-rheumatic drug (bDMARD) that has been approved for the treatment of patients with moderate-to-severe, active RA ...

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Structural and functional comparability study of anti-CD20 monoclonal antibody with reference product

Structural and functional comparability study of anti-CD20 monoclonal antibody with reference product

... biosimilar product. Any structural changes in the reference product and the biosimilar product must be characterized and evaluated for the evaluation of biological ...the reference ...

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Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers

Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers

... (NCT02725086). This was a randomized, open-label, 2-way crossover, single-dose study with a washout period of 28 days. There were 2 dosing parts (5 and 10 μ g/kg) in this study, with 2 sequences in them. In each ...

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Assessment of the efficacy of a patient hand wipe: development of a test method

Assessment of the efficacy of a patient hand wipe: development of a test method

... The standard comprises an assessment of the number of test organisms (E. coli) released from the fingertips of artificially-contaminated hands of 12 – 15 volunteers, before and after hygienic handwash with test and ...

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IN VITRO STUDIES OF AMLODIPINE BESYLATE TABLET AND COMPARISON WITH FOREIGN BRAND LEADER IN NEPAL

IN VITRO STUDIES OF AMLODIPINE BESYLATE TABLET AND COMPARISON WITH FOREIGN BRAND LEADER IN NEPAL

... test product complied the biowaiver condition of dissolution for BCS I drugs whereas the reference product did ...test product, especially in terms of hardness and friability, were found to be ...

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Phytochemical Characterization, Anti inflammatory and Anti ulcer Activity of a Spontaneous Succulent Delosperma Reseii

Phytochemical Characterization, Anti inflammatory and Anti ulcer Activity of a Spontaneous Succulent Delosperma Reseii

... The anti-inflammatory activity of the saponins extract appears less effective than that of Diclofenac. Indeed, the administration of saponins extract appears less effective compared to the administration of crude plant ...

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Bioequivalence Study of Morphine Hydrochloride Oral Solution versus Immediate Release Tablets

Bioequivalence Study of Morphine Hydrochloride Oral Solution versus Immediate Release Tablets

... test product (T, Morphine Hydrochloride, 5 ml oral solution 2 mg/ml) or reference product (R, Morphine Hydrochloride, 1 immediate release tablet 10 mg) was administered orally under fasting ...

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OVERVIEW OF BIOTECHNOLOGICALLY DERIVED PRODUCTS AND VARIOUS REGULATORY PARAMETERS FOR BIOSIMILARS IN EUROPEAN UNION

OVERVIEW OF BIOTECHNOLOGICALLY DERIVED PRODUCTS AND VARIOUS REGULATORY PARAMETERS FOR BIOSIMILARS IN EUROPEAN UNION

... Every pharmaceutical company must have a Pharmacovigilance system in place which is used by the marketing authorization holder to monitor the safety of authorized medicinal products and detect any change to their ...

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Use this product according to this instruction manual. Please keep this instruction manual for future reference.

Use this product according to this instruction manual. Please keep this instruction manual for future reference.

... P83273 A Wheelock products must be used within their published specifications and must be PROPERLY specified, applied, installed, operated, maintained and operationally tested in accordance with these instructions at the ...

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Use this product according to this instruction manual. Please keep this instruction manual for future reference.

Use this product according to this instruction manual. Please keep this instruction manual for future reference.

... Wheelock products must be used within their published specifications and must be PROPERLY specified, applied, installed, operated, maintained and operationally tested in accordance with these instructions at the time of ...

9

PuLSE-I: Deriving instances from a product line infrastructure

PuLSE-I: Deriving instances from a product line infrastructure

... PuLSE-I was developed to ensure a tight connection between the results created during product line infrastruc- ture development and the process that uses these results. The PuLSE method is in the same category as ...

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THE THROMBOTIC ACTIVITY OF ACTIVATION PRODUCT

THE THROMBOTIC ACTIVITY OF ACTIVATION PRODUCT

... The presence of preformed activation product in the eluate was confirmed by demonstrating that the eluate shortened the partial Per cent of standard reference activity in: thromboplastin[r] ...

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Effect of Clonal Variation on Quality of Kocho, Traditional Fermented Food from Enset          (Ensete Ventricosum), Musaceae

Effect of Clonal Variation on Quality of Kocho, Traditional Fermented Food from Enset (Ensete Ventricosum), Musaceae

... of product quality and ...final product, particularly in reference to the use as human food, to be recommended and selected as candidate varieties for the improvement of agriculture in selected ...

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A theory of reference for product design: the semantics of product ideation

A theory of reference for product design: the semantics of product ideation

... Rafael Lacruz-Rengel -A theory of reference for product design.... and therefore difficult to solve in a definite manner. Their unique nature means they could have many solutions o[r] ...

368

An Evaluation of Factors Influencing In New Product Innovation & Process - With Special Reference to Health Insurance

An Evaluation of Factors Influencing In New Product Innovation & Process - With Special Reference to Health Insurance

... New product development (NPD) has been an important activity for ...new product evaluation decisions and offering guidelines for effectively evaluating new ...new product evaluation, understanding ...

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Reference quality upper-air measurements: GRUAN data processing for the Vaisala RS92 radiosonde

Reference quality upper-air measurements: GRUAN data processing for the Vaisala RS92 radiosonde

... data product for the Vaisala RS92 radiosonde was developed to meet the criteria for reference measurements: traceability, the availability of metadata, and best estimates of the measurement ...data ...

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Low Temperature Phase Transition of Ilmenite during Oxidation by Chlorine

Low Temperature Phase Transition of Ilmenite during Oxidation by Chlorine

... The XRD patterns of the samples after oxidation are shown in Fig. 1. Disregarding the peaks of unreacted ilmenite and weak diffraction peaks of the rutile phase, the diffraction peaks of the oxidation product was in ...

6

Joint Graphical Models for Date Selection in Timeline Summarization

Joint Graphical Models for Date Selection in Timeline Summarization

... Competitors. We reimplement Kessler et al. (2012)’s model. It first detects all sentences with date references and filters out certain types of sen- tences according to linguistic features (such as presence of modality ...

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Evaluation of Skin Elasticising Topical  Formulations by a Torsiometric Test

Evaluation of Skin Elasticising Topical Formulations by a Torsiometric Test

... test product 2 in terms of increased extensibility and faster elastic recovery, on the volar forearm surface after ...test product 2 was designed to con- tain as the main ingredients: 1) a thiolated ...

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