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  • INTRAGAM® P
    for intravenous use infusion into a vein INTRAGAM P is prepared from blood obtained from Singapore s voluntary non remunerated donors INTRAGAM P is used to treat patients who need replacement of antibodies which form part of our immune system and can provide protection against some infections INTRAGAM P is also used in the treatment of some diseases when the immune system is overactive these are called autoimmune disorders INTRAGAM

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1217017237558/Web_Product_C/1196562733420/ProductDetail.htm (2014-01-05)
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  • CSL Limited and their involvement in clinical trials.
    humans it is first tested extensively in the laboratory and in animals Clinical trials are carefully supervised monitored and documented The applicable regulatory authority must grant approval to conduct testing in humans and clinical trials are overseen by an independent review body How are clinical trials conducted CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice GCP of the International Conference on Harmonisation ICH GCP is an international ethical and scientific quality standard for designing conducting and reporting studies that involve the participation of human subjects Compliance with this standard provides public assurance that the rights safety and well being of study subjects are protected and that the clinical trial data are credible Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki Current Studies All Bleeding Disorders Critical Care Immunoglobulins Pulmonary Therapeutic Proteins Vaccines Wound Healing Condition Additional Trial Information Congenital Fibrinogen Deficiency Fibrinogen Concentrate Human Efficacy and Safety Study Learn More Hemophilia A An Open label Safety Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A Learn More Hemophilia A Study of a Plasma Derived von Willebrand Factor Factor VIII Concentrate vWF FVIII Biostate in Subjects with Hemophilia A Learn More Hemophilia A Study of Biostate for Treatment of Children with Hemophilia A Complicated by Antibody Development Learn More Hemophilia A Study of a Plasma Derived von Willebrand Factor Factor VIII Concentrate vWF FVIII Biostate in Subjects with Hemophilia A Learn More Page 1 of 2 Last Trial Phases Following a positive outcome in preclinical testing the sponsoring organisation usually a drug manufacturer will seek approval to conduct clinical trials Once approval has been granted the sponsor will usually

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649386/page/1255926192841/TabsLandingPage.htm (2014-01-05)
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  • CSL Limited and their involvement in clinical trials.
    be tested in a clinical trial Most clinical trials look at a specific illness however many evaluate new medical procedures or even preventive measures Before a clinical trial can begin with humans it is first tested extensively in the laboratory and in animals Clinical trials are carefully supervised monitored and documented The applicable regulatory authority must grant approval to conduct testing in humans and clinical trials are overseen by an independent review body How are clinical trials conducted CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice GCP of the International Conference on Harmonisation ICH GCP is an international ethical and scientific quality standard for designing conducting and reporting studies that involve the participation of human subjects Compliance with this standard provides public assurance that the rights safety and well being of study subjects are protected and that the clinical trial data are credible Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki Current Studies All Bleeding Disorders Critical Care Immunoglobulins Pulmonary Therapeutic Proteins Vaccines Wound Healing Condition Additional Trial Information Hereditary Angioedema HAE Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert Learn More Hereditary Angioedema Types I and II A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 esterase Inhibitor in the Prevention of Hereditary Angioedema Learn More Page 1 of 1 Trial Phases Following a positive outcome in preclinical testing the sponsoring organisation usually a drug manufacturer will seek approval to conduct clinical trials Once approval has been granted the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment An optional fourth phase typically follows approval For each phase of a clinical

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649386/page/1255926192864/TabsLandingPage.htm (2014-01-05)
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  • CSL Limited and their involvement in clinical trials.
    of treatment can be tested in a clinical trial Most clinical trials look at a specific illness however many evaluate new medical procedures or even preventive measures Before a clinical trial can begin with humans it is first tested extensively in the laboratory and in animals Clinical trials are carefully supervised monitored and documented The applicable regulatory authority must grant approval to conduct testing in humans and clinical trials are overseen by an independent review body How are clinical trials conducted CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice GCP of the International Conference on Harmonisation ICH GCP is an international ethical and scientific quality standard for designing conducting and reporting studies that involve the participation of human subjects Compliance with this standard provides public assurance that the rights safety and well being of study subjects are protected and that the clinical trial data are credible Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki Current Studies All Bleeding Disorders Critical Care Immunoglobulins Pulmonary Therapeutic Proteins Vaccines Wound Healing Condition Additional Trial Information Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy CIDP and Treatment With Subcutaneous Immunoglobulin IgPro20 Learn More Immune Thrombocytopenic Purpura A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura ITP Learn More Page 1 of 1 Trial Phases Following a positive outcome in preclinical testing the sponsoring organisation usually a drug manufacturer will seek approval to conduct clinical trials Once approval has been granted the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment An optional fourth phase typically follows approval For each phase of a clinical trial the sponsor collaborates

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649386/page/1255926192887/TabsLandingPage.htm (2014-01-05)
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  • CSL Limited and their involvement in clinical trials.
    type of treatment can be tested in a clinical trial Most clinical trials look at a specific illness however many evaluate new medical procedures or even preventive measures Before a clinical trial can begin with humans it is first tested extensively in the laboratory and in animals Clinical trials are carefully supervised monitored and documented The applicable regulatory authority must grant approval to conduct testing in humans and clinical trials are overseen by an independent review body How are clinical trials conducted CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice GCP of the International Conference on Harmonisation ICH GCP is an international ethical and scientific quality standard for designing conducting and reporting studies that involve the participation of human subjects Compliance with this standard provides public assurance that the rights safety and well being of study subjects are protected and that the clinical trial data are credible Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki Current Studies All Bleeding Disorders Critical Care Immunoglobulins Pulmonary Therapeutic Proteins Vaccines Wound Healing Condition Additional Trial Information Emphysema Caused by API Deficiency Study of Zemaira i v Administration in Subjects Who Completed a 2 Year Controlled Study With This Treatment and Have Emphysema Due to alpha1 Proteinase Inhibitor Deficiency Learn More Page 1 of 1 Trial Phases Following a positive outcome in preclinical testing the sponsoring organisation usually a drug manufacturer will seek approval to conduct clinical trials Once approval has been granted the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment An optional fourth phase typically follows approval For each phase of a clinical trial the sponsor collaborates with

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649386/page/1255926192911/TabsLandingPage.htm (2014-01-05)
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  • CSL Limited and their involvement in clinical trials.
    terms of its safety and its effectiveness Any type of treatment can be tested in a clinical trial Most clinical trials look at a specific illness however many evaluate new medical procedures or even preventive measures Before a clinical trial can begin with humans it is first tested extensively in the laboratory and in animals Clinical trials are carefully supervised monitored and documented The applicable regulatory authority must grant approval to conduct testing in humans and clinical trials are overseen by an independent review body How are clinical trials conducted CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice GCP of the International Conference on Harmonisation ICH GCP is an international ethical and scientific quality standard for designing conducting and reporting studies that involve the participation of human subjects Compliance with this standard provides public assurance that the rights safety and well being of study subjects are protected and that the clinical trial data are credible Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki Current Studies All Bleeding Disorders Critical Care Immunoglobulins Pulmonary Therapeutic Proteins Vaccines Wound Healing Condition Additional Trial Information Leukemia Myeloid Acute A Study of CSL362 in Patients With CD123 Acute Myeloid Leukemia Currently in Remission Learn More Page 1 of 1 Trial Phases Following a positive outcome in preclinical testing the sponsoring organisation usually a drug manufacturer will seek approval to conduct clinical trials Once approval has been granted the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment An optional fourth phase typically follows approval For each phase of a clinical trial the sponsor collaborates with physicians to conduct the clinical trial prepares

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649386/page/1255926192934/TabsLandingPage.htm (2014-01-05)
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  • CSL Limited and their involvement in clinical trials.
    as a drug and be observed for its effects both in terms of its safety and its effectiveness Any type of treatment can be tested in a clinical trial Most clinical trials look at a specific illness however many evaluate new medical procedures or even preventive measures Before a clinical trial can begin with humans it is first tested extensively in the laboratory and in animals Clinical trials are carefully supervised monitored and documented The applicable regulatory authority must grant approval to conduct testing in humans and clinical trials are overseen by an independent review body How are clinical trials conducted CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice GCP of the International Conference on Harmonisation ICH GCP is an international ethical and scientific quality standard for designing conducting and reporting studies that involve the participation of human subjects Compliance with this standard provides public assurance that the rights safety and well being of study subjects are protected and that the clinical trial data are credible Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki Current Studies All Bleeding Disorders Critical Care Immunoglobulins Pulmonary Therapeutic Proteins Vaccines Wound Healing Condition Additional Trial Information Trial Phases Following a positive outcome in preclinical testing the sponsoring organisation usually a drug manufacturer will seek approval to conduct clinical trials Once approval has been granted the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment An optional fourth phase typically follows approval For each phase of a clinical trial the sponsor collaborates with physicians to conduct the clinical trial prepares a plan or protocol that describes the clinical trial and submits detailed

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649386/page/1255926192957/TabsLandingPage.htm (2014-01-05)
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  • CSL Limited and their involvement in clinical trials.
    both in terms of its safety and its effectiveness Any type of treatment can be tested in a clinical trial Most clinical trials look at a specific illness however many evaluate new medical procedures or even preventive measures Before a clinical trial can begin with humans it is first tested extensively in the laboratory and in animals Clinical trials are carefully supervised monitored and documented The applicable regulatory authority must grant approval to conduct testing in humans and clinical trials are overseen by an independent review body How are clinical trials conducted CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice GCP of the International Conference on Harmonisation ICH GCP is an international ethical and scientific quality standard for designing conducting and reporting studies that involve the participation of human subjects Compliance with this standard provides public assurance that the rights safety and well being of study subjects are protected and that the clinical trial data are credible Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki Current Studies All Bleeding Disorders Critical Care Immunoglobulins Pulmonary Therapeutic Proteins Vaccines Wound Healing Condition Additional Trial Information Hereditary Angioedema HAE Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert Learn More Page 1 of 1 Trial Phases Following a positive outcome in preclinical testing the sponsoring organisation usually a drug manufacturer will seek approval to conduct clinical trials Once approval has been granted the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment An optional fourth phase typically follows approval For each phase of a clinical trial the sponsor collaborates with physicians to conduct the clinical trial prepares a plan or

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649386/page/1255926192980/TabsLandingPage.htm (2014-01-05)
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