(Q30528376)

13 August 2017

Uncertainty estimates of purity measurements based on current information: toward a "live validation" of purity methods (English)

1 reference

13 August 2017

14

Wojciech Szpankowski

1 reference

13 August 2017

Izydor Apostol

1

1 reference

13 August 2017

Drew Kelner

2

1 reference

13 August 2017

Xinzhao Grace Jiang

3

1 reference

13 August 2017

Gang Huang

4

1 reference

13 August 2017

Jette Wypych

5

1 reference

13 August 2017

Xin Zhang

6

1 reference

13 August 2017

Jessica Gastwirt

7

1 reference

13 August 2017

Kenneth Chen

8

1 reference

13 August 2017

Szilan Fodor

9

1 reference

13 August 2017

Suminda Hapuarachchi

10

1 reference

13 August 2017

Dave Meriage

11

1 reference

13 August 2017

Frank Ye

12

1 reference

13 August 2017

Leszek Poppe

13

1 reference

13 August 2017

15 August 2012

1 reference

13 August 2017

Pharmaceutical Research

1 reference

13 August 2017

29

1 reference

13 August 2017

12

1 reference

13 August 2017

3404-3419

1 reference

Options and considerations when selecting a quantitative proteomics strategy

13 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3497960

Quality by design for biopharmaceuticals

20 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3497960

Statistical based impulsive noise removal in digital radiography.

20 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3497960

Validation in pharmaceutical analysis. Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data

20 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3497960

Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: role in restricted conformational mobility and compaction of native state

20 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3497960

How to measure and predict the molar absorption coefficient of a protein

20 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3497960

A proposed "fixed" range decision criteria for transfer of bioanalytical methods

20 June 2018

1 reference

https://api.crossref.org/works/10.1007%2FS11095-012-0836-Z

Validation of HPLC and GC-MS systems for bisphenol-A leached from hemodialyzers on the basis of FUMI theory

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS11095-012-0836-Z

Precision, limit of detection and range of quantitation in competitive ELISA.

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS11095-012-0836-Z

Comparison of different approaches for evaluation of the detection and quantitation limits of a purity method: a case study using a capillary isoelectrofocusing method for a monoclonal antibody.

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS11095-012-0836-Z

Large-scale identification and quantification of covalent modifications in therapeutic proteins

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS11095-012-0836-Z

Gas-phase oligosaccharide nonreducing end (GONE) sequencing and structural analysis by reversed phase HPLC/mass spectrometry with polarity switching.

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS11095-012-0836-Z

Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS11095-012-0836-Z

Quantitation of proteins using HPLC-detector response rather than standard curve comparison

21 January 2018

1 reference

12 December 2020

Least detectable concentration and dynamic range of three immunoassay systems using the same antibody

1 reference

12 December 2020

Analysis of N-glycans from recombinant immunoglobulin G by on-line reversed-phase high-performance liquid chromatography/mass spectrometry

1 reference

12 December 2020

Analytical method transfer: new descriptive approach for acceptance criteria definition

1 reference

12 December 2020

Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the Internationa

1 reference

12 December 2020

10.1007/S11095-012-0836-Z

Identifiers

DOI

1 reference

13 August 2017

1 reference

13 August 2017

1 reference