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Committee for medicinal products for human use. Guideline on similar biological medicinal products. CHMP/437/04 2005.
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Committee for medicinal products for human use. Guideline on similar biological medicinal products. CHMP/437/04 2005.
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The Economic impact of new biotechnological agents: how does it affect the pharmaceutical expenditure?. 10th Congress of the European Association of Hospital Pharmacists, Lisbon, Portugal, March 2005.
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The Economic impact of new biotechnological agents: how does it affect the pharmaceutical expenditure?. 10th Congress of the European Association of Hospital Pharmacists, Lisbon, Portugal, March 2005.
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Satellite symposium report: Biosimilars: How similar are they?. EJHP 2005; 3: 23-5.
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Satellite symposium report: Biosimilars: How similar are they?. EJHP 2005; 3: 23-5.
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5
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The supply chain for biopharmaceuticals: Maintaining the correct temperature
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Tredree R. The supply chain for biopharmaceuticals: maintaining the correct temperature. EJHP 2007; 13: 52-4.
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Tredree, R.1
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Crommelin D, Bermejo T, Bissig M et al. Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals. EJHP 2005; 11: 11-7.
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Crommelin, D.1
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10
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EMEA/CHMP/42832/05. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues (CHMP adopted Feb 2006).
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EMEA/CHMP/42832/05. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues (CHMP adopted Feb 2006).
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11
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EMEA/CHMP/BWP/49348/05. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues (CHMP adopted Feb 2006).
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EMEA/CHMP/BWP/49348/05. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues (CHMP adopted Feb 2006).
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41149168491
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EMEA/CHMP/32775/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing recombinant Human Insulin (CHMP adopted Feb 2006).
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EMEA/CHMP/32775/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing recombinant Human Insulin (CHMP adopted Feb 2006).
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13
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41149157809
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EMEA/CHMP/94526/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing recombinant Erythropoietins (CHMP adopted March 2006).
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EMEA/CHMP/94526/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing recombinant Erythropoietins (CHMP adopted March 2006).
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14
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41149145008
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EMEA/CHMP/94528/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing Somatropin (CHMP adopted Feb 2006).
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EMEA/CHMP/94528/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing Somatropin (CHMP adopted Feb 2006).
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15
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41149174517
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EMEA/CHMP/31329/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing recombinant Granulocyte-Colony Stimulating Factor (CHMP adopted Feb 2006).
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EMEA/CHMP/31329/05. Annex Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues-Guidance on similar medicinal products containing recombinant Granulocyte-Colony Stimulating Factor (CHMP adopted Feb 2006).
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Mikhail A. Legal and regulatory issues in licensing biosimilars. EJHP 2007; 13: 56-9.
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Mikhail, A.1
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BOE núm.239: 17420 Orden SCO/2874/2007, 28 septiembre. Ministerio Sanidad y Consumo.
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BOE núm.239: 17420 Orden SCO/2874/2007, 28 septiembre. Ministerio Sanidad y Consumo.
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