(Q38142892)

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

title

How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider (English)

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

7

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

author name string

Huub Schellekens

1

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

Sven Stegemann

2

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

Vera Weinstein

3

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

Jon S B de Vlieger

4

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

Beat Flühmann

5

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

Stefan Mühlebach

6

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

Vinod P Shah

8

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

Daan J A Crommelin

9

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

language of work or name

English

0 references

publication date

25 September 2013

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

volume

16

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

issue

1

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

page(s)

15-21

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

https://scigraph.springernature.com/pub.10.1208/s12248-013-9533-z

23 February 2020

exact match

0 references

cites work

Different pharmaceutical products need similar terminology

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Doxil®--the first FDA-approved nano-drug: lessons learned

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Comparison of oxidative stress and inflammation induced by different intravenous iron sucrose similar preparations in a rat model

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Clinical development of liposome-based drugs: formulation, characterization, and therapeutic efficacy

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Do two intravenous iron sucrose preparations have the same efficacy?

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Gene expression analysis reveals functional pathways of glatiramer acetate activation.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients

31 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies

31 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator

31 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3889532

The glatiramoid class of immunomodulator drugs

31 August 2018

1 reference

12 December 2020

The therapeutic equivalence of complex drugs

1 reference

12 December 2020

Effects of intravenous iron on mononuclear cells during the haemodialysis session

1 reference

12 December 2020

Evidence for tissue iron overload in long-term hemodialysis patients and the impact of withdrawing parenteral iron

1 reference

12 December 2020

Scientific considerations for complex drugs in light of established and emerging regulatory guidance

1 reference

12 December 2020

Pharmacokinetics, efficacy and toxicity of different pegylated liposomal doxorubicin formulations in preclinical models: is a conventional bioequivalence approach sufficient to ensure therapeutic equivalence of pegylated liposomal doxorubicin produc

1 reference

12 December 2020

10.1208/S12248-013-9533-Z

Identifiers

DOI

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

Dimensions Publication ID

23 February 2020

0 references

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json

23 February 2020

PubMed publication ID

24065600

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:24065600%20AND%20SRC:MED&resulttype=core&format=json