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Biosimilar
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611	Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceutical industry Food and Drug Administration Biotechnology Biosimilar Biologic Validation Pharmacokinetics New Drug Application Pharmaceutical sciences Pharmacology Medicine
612	Microsoft Word[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical research Pharmaceutical industry Pharmaceuticals policy Biosimilar New Drug Application Biologic Center for Biologics Evaluation and Research Regulatory requirement Pharmaceutical sciences Medicine Food and Drug Administration
613	Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Add to Reading List Source URL: www.personalizedmedicinecoalition.org Language: English - Date: 2014-05-15 14:30:36 Clinical research Pharmaceutical industry Food and Drug Administration Biotechnology Biosimilar Biologic Validation Pharmacokinetics New Drug Application Pharmaceutical sciences Pharmacology Medicine
614	WHITE PAPER Author: Hazel Gorham, PhD Director, Biosimilars Development, Add to Reading List Source URL: www.prainternational.com Language: English - Date: 2014-01-13 10:55:48 Clinical research Pharmaceutical industry Food and Drug Administration Clinical pharmacology Biosimilar Biologic Clinical trial European Medicines Agency Drug discovery Pharmaceutical sciences Research Pharmacology
615	Whitepaper_Biosimilars Podcast_APR2013_alg.indd Add to Reading List Source URL: www.prainternational.com Language: English - Date: 2013-06-19 15:02:23 Biosimilar Biotechnology Drugs Pharmaceutical industry Biologic Food and Drug Administration Regulatory requirement Clinical trial Pharmaceutical sciences Pharmacology Clinical research
616	Biosimilars Expertise Transform Add to Reading List Source URL: www.prainternational.com Language: English - Date: 2013-06-10 19:56:28 Biotechnology Medicine Drugs Biosimilar Biologic Food and Drug Administration Monoclonal antibodies Clinical trial Goodwin Biotechnology Pharmacology Clinical research Pharmaceutical sciences
617	WHITE PAPER Author: Hazel Gorham, PhD Director, Biosimilars Development, PRA The Value of Add to Reading List Source URL: www.praintl.com Language: English - Date: 2014-01-13 10:55:48 Clinical research Pharmaceutical industry Food and Drug Administration Clinical pharmacology Biosimilar Biologic Clinical trial European Medicines Agency Drug discovery Pharmaceutical sciences Research Pharmacology
618	Human Medicines Highlights Newsletter Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2013-10-04 09:54:18 Biotechnology Clinical research Pharmaceutical industry European Medicines Agency Committee for Medicinal Products for Human Use Certolizumab pegol Summary of Product Characteristics Biosimilar Adverse effect Pharmacology Medicine Pharmaceutical sciences
619	BH 1204_Spotlight_24kta.indd Add to Reading List Source URL: www.ncbi.nlm.nih.gov Language: English Pharmaceutical industry Prescription Drug User Fee Act Biosimilar Food and Drug Administration Biotechnology Biologic Pharmaceutical drug Pharmacology Pharmaceutical sciences Clinical research
620	UBM brochure cover FINAL v2 Add to Reading List Source URL: itec.com.vn Language: English - Date: 2014-03-07 04:49:24 Pharmaceutical industry Pharmacy Biosimilar Global sourcing Food and Drug Administration Sourcing Pharmaceutical sciences Pharmacology Clinical research

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