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Scientific Literature on Generics and CopiesComplete Cytogenetic Response
Absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Complete Hematologic Response
The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
Gastrointestinal tumours
Tumours of the gastrointestinal tract which is commonly defined as the stomach and the intestine.
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
First-line therapy
The first treatment given after a disease has been diagnosed. Patients who do not respond to or do not tolerate this treatment, will receive second-line therapy.
Also called induction therapy or primary treatment.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
Chronic phase
The earliest phase of CML development.
Response rate
Proportion of patients (in percent) in whom a specific therapy led to a decrease in or disappearance of signs and symptoms of a disease.
Adverse event
An undesired or unintended occurrence or side effect that has a temporal relationship with the use of a medical treatment or procedure in a clinical study. An adverse event does not necessarily have a causal relationship with the study treatment.
Also called: AE
Generic drug
A medical product that is comparable to a brand/reference listed medical product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent protection and market exclusivity ends
Blast crisis
The third phase of development of CML after chronic and accelerated phases. It is characterized by the presence of increasing numbers of immature blood cells ("blasts") in the blood and bone marrow.
Hematologist
A physician who has specialized in blood diseases, including leukemia ("heme" means "blood" in Greek language)
Chemotherapy
Chemotherapy is the use of drugs to treat cancer by destroying or slowing the growth of fast-growing cancer cells. The term chemotherapy also includes treatment with antibiotics.
Pharmacology
The science of the interactions between drugs and the body
Biosimilars
Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance is made by a living organism or derived from a living organism. Biosimilars or follow-on biologics are terms used to describe officially approved subsequent versions of biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the original product
Progression
Worsening of a cancer
Side effect
Adverse effects of a treatment:, side effects limit the maximum tolerable dose in particular during chemotherapy.
Resistance
The ability to withstand the effects of a drug, e.g. resistance of cancer cells to a specific therapy.
Brand name
Name under which a drug is marketed by a specific manufacturer, which is different to the compound name which describes the active ingredient contained in a pharmaceutical product
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
Compliance
Willingness of a patient to reliably adhere to treatment measures and follow medical instructions.
Absorption
Uptake of a drug into the bloodstream
Copy drug
A medicine provided by third party manufacturers despite the medicine is still patented
Apoptosis
Programmed cell death, triggered actively by the cell.
Cytopenia
The condition of having a deficient number of one or more elements in the blood. Depending on which types of blood cells are decreased, the condition is also called leuko(cyto)penia, granulopenia, lympho(cyto)penia, mono(cyto)penia, erythro(cyto)penia or thrombo(cyto)penia.
Generics
A class of medicinal products where the drug is comparable to a branded product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent exclusivity protection ends.
Toxicity
The quality of being poisonous; harm resulting from drugs, e.g. side effects of chemotherapy.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
Aplasia
Condition where the bone marrow is defective and cannot form any blood cells
Symptom
A sign of disease or disorder (Greek; accident, happening)
Anemia
Lack of red blood cells or decrease in red blood pigment (haemoglobin)
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
CCyR
Abbreviation for Complete Cytogenetic Response, which is the absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
Oral
Oral, pertaining to the mouth; taken through or applied in the mouth.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
ASH
American Society of Hematology
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
GUS
ß-glucuronidase; an enzyme
CAM
Complementary and Alternative Medicine
APL
Acute promyelocytic leukemia; a subtype of acute myelogenous leukemia (AML)
Complete Cytogenetic Response
Absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Complete Hematologic Response
The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
Gastrointestinal tumours
Tumours of the gastrointestinal tract which is commonly defined as the stomach and the intestine.
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
First-line therapy
The first treatment given after a disease has been diagnosed. Patients who do not respond to or do not tolerate this treatment, will receive second-line therapy.
Also called induction therapy or primary treatment.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
Chronic phase
The earliest phase of CML development.
Response rate
Proportion of patients (in percent) in whom a specific therapy led to a decrease in or disappearance of signs and symptoms of a disease.
Adverse event
An undesired or unintended occurrence or side effect that has a temporal relationship with the use of a medical treatment or procedure in a clinical study. An adverse event does not necessarily have a causal relationship with the study treatment.
Also called: AE
Generic drug
A medical product that is comparable to a brand/reference listed medical product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent protection and market exclusivity ends
Blast crisis
The third phase of development of CML after chronic and accelerated phases. It is characterized by the presence of increasing numbers of immature blood cells ("blasts") in the blood and bone marrow.
Hematologist
A physician who has specialized in blood diseases, including leukemia ("heme" means "blood" in Greek language)
Chemotherapy
Chemotherapy is the use of drugs to treat cancer by destroying or slowing the growth of fast-growing cancer cells. The term chemotherapy also includes treatment with antibiotics.
Pharmacology
The science of the interactions between drugs and the body
Biosimilars
Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance is made by a living organism or derived from a living organism. Biosimilars or follow-on biologics are terms used to describe officially approved subsequent versions of biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the original product
Progression
Worsening of a cancer
Side effect
Adverse effects of a treatment:, side effects limit the maximum tolerable dose in particular during chemotherapy.
Resistance
The ability to withstand the effects of a drug, e.g. resistance of cancer cells to a specific therapy.
Brand name
Name under which a drug is marketed by a specific manufacturer, which is different to the compound name which describes the active ingredient contained in a pharmaceutical product
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
Compliance
Willingness of a patient to reliably adhere to treatment measures and follow medical instructions.
Absorption
Uptake of a drug into the bloodstream
Copy drug
A medicine provided by third party manufacturers despite the medicine is still patented
Apoptosis
Programmed cell death, triggered actively by the cell.
Cytopenia
The condition of having a deficient number of one or more elements in the blood. Depending on which types of blood cells are decreased, the condition is also called leuko(cyto)penia, granulopenia, lympho(cyto)penia, mono(cyto)penia, erythro(cyto)penia or thrombo(cyto)penia.
Generics
A class of medicinal products where the drug is comparable to a branded product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent exclusivity protection ends.
Toxicity
The quality of being poisonous; harm resulting from drugs, e.g. side effects of chemotherapy.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
Aplasia
Condition where the bone marrow is defective and cannot form any blood cells
Symptom
A sign of disease or disorder (Greek; accident, happening)
Anemia
Lack of red blood cells or decrease in red blood pigment (haemoglobin)
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
CCyR
Abbreviation for Complete Cytogenetic Response, which is the absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
Oral
Oral, pertaining to the mouth; taken through or applied in the mouth.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
ASH
American Society of Hematology
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
GUS
ß-glucuronidase; an enzyme
CAM
Complementary and Alternative Medicine
APL
Acute promyelocytic leukemia; a subtype of acute myelogenous leukemia (AML)
These are scientific articles and other publications e.g. on bioquivalence studies or trials run on CML generics or copy drugs.
Complete Cytogenetic Response
Absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Complete Hematologic Response
The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
Gastrointestinal tumours
Tumours of the gastrointestinal tract which is commonly defined as the stomach and the intestine.
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
First-line therapy
The first treatment given after a disease has been diagnosed. Patients who do not respond to or do not tolerate this treatment, will receive second-line therapy.
Also called induction therapy or primary treatment.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
Chronic phase
The earliest phase of CML development.
Response rate
Proportion of patients (in percent) in whom a specific therapy led to a decrease in or disappearance of signs and symptoms of a disease.
Adverse event
An undesired or unintended occurrence or side effect that has a temporal relationship with the use of a medical treatment or procedure in a clinical study. An adverse event does not necessarily have a causal relationship with the study treatment.
Also called: AE
Generic drug
A medical product that is comparable to a brand/reference listed medical product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent protection and market exclusivity ends
Blast crisis
The third phase of development of CML after chronic and accelerated phases. It is characterized by the presence of increasing numbers of immature blood cells ("blasts") in the blood and bone marrow.
Hematologist
A physician who has specialized in blood diseases, including leukemia ("heme" means "blood" in Greek language)
Chemotherapy
Chemotherapy is the use of drugs to treat cancer by destroying or slowing the growth of fast-growing cancer cells. The term chemotherapy also includes treatment with antibiotics.
Pharmacology
The science of the interactions between drugs and the body
Biosimilars
Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance is made by a living organism or derived from a living organism. Biosimilars or follow-on biologics are terms used to describe officially approved subsequent versions of biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the original product
Progression
Worsening of a cancer
Side effect
Adverse effects of a treatment:, side effects limit the maximum tolerable dose in particular during chemotherapy.
Resistance
The ability to withstand the effects of a drug, e.g. resistance of cancer cells to a specific therapy.
Brand name
Name under which a drug is marketed by a specific manufacturer, which is different to the compound name which describes the active ingredient contained in a pharmaceutical product
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
Compliance
Willingness of a patient to reliably adhere to treatment measures and follow medical instructions.
Absorption
Uptake of a drug into the bloodstream
Copy drug
A medicine provided by third party manufacturers despite the medicine is still patented
Apoptosis
Programmed cell death, triggered actively by the cell.
Cytopenia
The condition of having a deficient number of one or more elements in the blood. Depending on which types of blood cells are decreased, the condition is also called leuko(cyto)penia, granulopenia, lympho(cyto)penia, mono(cyto)penia, erythro(cyto)penia or thrombo(cyto)penia.
Generics
A class of medicinal products where the drug is comparable to a branded product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent exclusivity protection ends.
Toxicity
The quality of being poisonous; harm resulting from drugs, e.g. side effects of chemotherapy.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
Aplasia
Condition where the bone marrow is defective and cannot form any blood cells
Symptom
A sign of disease or disorder (Greek; accident, happening)
Anemia
Lack of red blood cells or decrease in red blood pigment (haemoglobin)
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
CCyR
Abbreviation for Complete Cytogenetic Response, which is the absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
Oral
Oral, pertaining to the mouth; taken through or applied in the mouth.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
ASH
American Society of Hematology
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
GUS
ß-glucuronidase; an enzyme
CAM
Complementary and Alternative Medicine
APL
Acute promyelocytic leukemia; a subtype of acute myelogenous leukemia (AML)
Complete Cytogenetic Response
Absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Complete Hematologic Response
The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
Gastrointestinal tumours
Tumours of the gastrointestinal tract which is commonly defined as the stomach and the intestine.
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
First-line therapy
The first treatment given after a disease has been diagnosed. Patients who do not respond to or do not tolerate this treatment, will receive second-line therapy.
Also called induction therapy or primary treatment.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
Chronic phase
The earliest phase of CML development.
Response rate
Proportion of patients (in percent) in whom a specific therapy led to a decrease in or disappearance of signs and symptoms of a disease.
Adverse event
An undesired or unintended occurrence or side effect that has a temporal relationship with the use of a medical treatment or procedure in a clinical study. An adverse event does not necessarily have a causal relationship with the study treatment.
Also called: AE
Generic drug
A medical product that is comparable to a brand/reference listed medical product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent protection and market exclusivity ends
Blast crisis
The third phase of development of CML after chronic and accelerated phases. It is characterized by the presence of increasing numbers of immature blood cells ("blasts") in the blood and bone marrow.
Hematologist
A physician who has specialized in blood diseases, including leukemia ("heme" means "blood" in Greek language)
Chemotherapy
Chemotherapy is the use of drugs to treat cancer by destroying or slowing the growth of fast-growing cancer cells. The term chemotherapy also includes treatment with antibiotics.
Pharmacology
The science of the interactions between drugs and the body
Biosimilars
Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance is made by a living organism or derived from a living organism. Biosimilars or follow-on biologics are terms used to describe officially approved subsequent versions of biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the original product
Progression
Worsening of a cancer
Side effect
Adverse effects of a treatment:, side effects limit the maximum tolerable dose in particular during chemotherapy.
Resistance
The ability to withstand the effects of a drug, e.g. resistance of cancer cells to a specific therapy.
Brand name
Name under which a drug is marketed by a specific manufacturer, which is different to the compound name which describes the active ingredient contained in a pharmaceutical product
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
Compliance
Willingness of a patient to reliably adhere to treatment measures and follow medical instructions.
Absorption
Uptake of a drug into the bloodstream
Copy drug
A medicine provided by third party manufacturers despite the medicine is still patented
Apoptosis
Programmed cell death, triggered actively by the cell.
Cytopenia
The condition of having a deficient number of one or more elements in the blood. Depending on which types of blood cells are decreased, the condition is also called leuko(cyto)penia, granulopenia, lympho(cyto)penia, mono(cyto)penia, erythro(cyto)penia or thrombo(cyto)penia.
Generics
A class of medicinal products where the drug is comparable to a branded product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent exclusivity protection ends.
Toxicity
The quality of being poisonous; harm resulting from drugs, e.g. side effects of chemotherapy.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
Aplasia
Condition where the bone marrow is defective and cannot form any blood cells
Symptom
A sign of disease or disorder (Greek; accident, happening)
Anemia
Lack of red blood cells or decrease in red blood pigment (haemoglobin)
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
CCyR
Abbreviation for Complete Cytogenetic Response, which is the absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
Oral
Oral, pertaining to the mouth; taken through or applied in the mouth.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
ASH
American Society of Hematology
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
GUS
ß-glucuronidase; an enzyme
CAM
Complementary and Alternative Medicine
APL
Acute promyelocytic leukemia; a subtype of acute myelogenous leukemia (AML)
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