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Biopharmaceutical Drug Development: Quality, Regulatory, Manufacturing

Analysis and Characterisation 1 / 1

Analytical Procedure Development 23 / 31

Specification Setting 3 / 7

Method Validation 1 / 1

Pharmaceutical Manufacturing 0 / 0

Pharmaceutical Data Integrity 0 / 0

Pharmaceutical Generative AI 0 / 0

Status

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Forum

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Last Post

Number of replicates

By Event Participant, Apr 18

Analytical Procedure Development

By Cari - BioQC

2 days ago

Robustness

By Event Participant, Apr 18

Analytical Procedure Development

By Quality Expert...

4 weeks ago

Analytical Target Profile

By Tamara Grant, Jan 15

Analytical Procedure Development

400

By Quality Expert...

4 weeks ago

CRO or Dossier Holder responsible for Specification

By Event Participant, Jun 12

Specification Setting

By Quality Expert...

2 weeks ago

Potency Testing

By Event Participant, Apr 18

Analysis and Characterisation

By Event Particip...

2 months ago

Patient-centric specifications and structure function relationship

By Event Participant, Jun 13

Specification Setting

By Quality Expert...

2 weeks ago

Production specification (NOR) and Regulatory specifications (POR) without DoE

By Event Participant, Jun 11

Specification Setting

By Quality Expert...

2 weeks ago

Established conditions CGT

By Event Participant, Apr 18

Analytical Procedure Development

By Quality Expert...

2 weeks ago

Risk assessment of Critical Method Parameters (CMPs)

By Event Participant, Apr 18

Analytical Procedure Development

By Quality Expert...

4 weeks ago

Control Strategy

By Event Participant, Apr 18

Analytical Procedure Development

By Quality Expert...

1 month ago

Statistical Consultant Agencies and JMP Software

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Established conditions without robustness study

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

ATP and filings

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Enhanced Approach and ICH Q14

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

MODR and method changes

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Method Operable Design Region (MODR)

By Event Participant, Apr 18

Analytical Procedure Development

165

By Event Particip...

2 months ago

ICH Q14 software

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Method bridging

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

ICH Q14: software-assisted method development

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

ICH Q14: Enhanced approach vs conventional approach

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

ICH Q14: Enhanced approach vs conventional approach

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Mandatory to follow ICH Q14 for method development?

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Practical approach for following ICH Q14

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Applying ICH Q14 retrospectively

By Event Participant, Apr 18

Analytical Procedure Development

161

By Event Particip...

2 months ago

Assessment of assay criteria

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

ICH Q14: characterisation vs release method

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

2 months ago

Trending vs Validation

By Event Participant, Apr 18

Method Validation

By Event Particip...

2 months ago

ICH Q14

By Jeroen Reiniers, Dec 11

Analytical Procedure Development

200

By Tamara Grant

5 months ago

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Biopharmaceutical Drug Development: Quality, Regulatory, Manufacturing

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