Literature DB >> 22781671

Debate over details of US biosimilar pathway continues to rage.

Jeffrey L Fox.   

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Year:  2012        PMID: 22781671     DOI: 10.1038/nbt0712-577

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN: 1087-0156            Impact factor:   54.908


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  1 in total

1.  Biotech innovators jump on biosimilars bandwagon.

Authors:  Nuala Moran
Journal:  Nat Biotechnol       Date:  2012-04-10       Impact factor: 54.908

  1 in total
  2 in total

1.  Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.

Authors:  Niels S Vermeer; Sabine M J M Straus; Aukje K Mantel-Teeuwisse; Francois Domergue; Toine C G Egberts; Hubert G M Leufkens; Marie L De Bruin
Journal:  Drug Saf       Date:  2013-08       Impact factor: 5.606

Review 2.  A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).

Authors:  David R Jones; James W McBlane; Graham McNaughton; Nishanthan Rajakumaraswamy; Kirsty Wydenbach
Journal:  Br J Clin Pharmacol       Date:  2013-08       Impact factor: 4.335

  2 in total

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