Search Results for "Imatinib Bioequivalence Generic"

03:09 EST 20th February 2020 | BioPortfolio

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Bcr Abl and Src Kinase Inhibitors

Chronic myeloid leukemia (CML) is characterized by the presence of the Philadelphia (Ph) chromosome, which results from a reciprocal translocation between the long arms of the chromosomes 9 and 22 t...

Chronic Myelocytic Leukemia CML

Chronic myelocytic leukemia is the resulting disease when neutrophil, basophil, eosinophil, and monocyte progenitors become cancerous. It is usually caused by the presence of the Philadelphia chromo...

Insulin like Growth Factor 1 Receptor IGF 1R

Although the insulin-like growth factor-1 receptor (IGF-1R) was first cloned in 1986, it was the success of targeted drugs such as trastuzumab and imatinib that tyrosine kinase inhibitors and growth...

TASH Biotechnology

Shanghai TASH Biotechnology Co.,Ltd. specializes in peptide development on the basis of high technology. TASH Biotechnology are focusing on custom peptide synthesis, and the research, development...

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Impact Story: Developing New Ways to Evaluate Bioequivalence for Topical Drugs

FDA-CDER is developing new methods to overcome challenges involved in establishing the bioequivalence of topical generic drugs.

Lupin launches generic Gleevec

TAS-116 inhibits oncogenic KIT signalling on the Golgi in both imatinib-naïve and imatinib-resistant gastrointestinal stromal tumours

A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease

Prices Drop At Last for Transformative Cancer Drug

When its generic version of imatinib first hit the marketplace, the price tag was nearly indistinguishable from the branded product, but the times 'they are a-changing.' Medscape Medical News

Certara technology achieves first FDA virtual bioequivalence approval for a complex generic drug

In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.

In-vitro models reduce ‘risk and cost’ for topically-delivered generics

Developers of generic drugs administered with topical drug delivery methods benefit from MedPharmâs in-vitro models to safely demonstrate bioequivalence.

Neoadjuvant Imatinib for an Uncommon Breast Malignancy

This case highlights the differentiation of dermatofibrosarcoma protuberans from metaplastic breast carcinoma and other spindle cell lesions, as well as the use of imatinib as neoadjuvant treatment. ...

Matching PubMed Articles

Expenditures for First- and Second-Generation Tyrosine Kinase Inhibitors Before and After Transition of Imatinib to Generic Status.

Imatinib introduced a paradigm shift in the treatment of patients with chronic myeloid leukemia (CML), allowing a lifespan that is almost comparable to the general population. However, the health care...

Analysis of correlation between plasma trough level and response of generic imatinib in the treatment of Chinese patients with chronic myeloid leukemia.

To analyze the correlation between plasma trough level of generic imatinib and its metabolism and clinical outcomes in Chinese patients with chronic myeloid leukemia in chronic phase (CML-CP) . The 2...

Comparison of the efficacy and safety of Chinese generic imatinib and branded imatinib in patients with chronic myeloid leukemia in consideration of demographic characteristics.

To compare the efficacy and safety of Chinese generic imatinib with branded imatinib as frontline therapy in adults with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) (Frontline g...

Is Bioequivalence a Sufficient Measure of Equivalence?

This article reviews the U.S. Food and Drug Administration (FDA) regulation of generic medications-specifically, the use of bioequivalence to compare generic and brand prescriptions. New or "brand" dr...

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of atorvastatin in Chinese subjects

The purpose of this study was to evaluate the bioequivalence of two formulations of atorvastatin using the reference-scaled average bioequivalence (RSABE) method and to study the pharmacokinetics of a...

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