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DMPK Resources

Links to some of my industry publications and Regulatory guidance(s): 

Approaches for Reducing Liability to Major Metabolically Driven Causes Of Drug Attrition: The Challenge To De-Risk Pharmaceuticals (Pharma Outsourcing)

https://www.pharmoutsourcing.com/Featured-Articles/346854-Approaches-for-Reducing-Liability-to-Major-Metabolically-Driven-Causes-of-Drug-Attrition-The-Challenge-to-De-Risk-Pharmaceuticals/

De-Risking Drug Development (Medicine Maker)

https://themedicinemaker.com/manufacture/de-risking-drug-development

The use of radiolabelled compounds in the investigation of Metabolism and Drug-Drug Interactions in vitro (PharmaChem, p2 onwards)

https://en.calameo.com/read/0001513130bff72926102

Drug Transporters: Emerging Technologies (PharmaChem, p13 onwards)

https://en.calameo.com/read/0001513138c832bfeee8e

Useful Regulatory Guidance

Drug-Drug Interactions (DDI):

**New FDA DDI Draft Guidance, January 2020**

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/vitro-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions

Current EMA (Europe) DDI Draft Guidance, July, 2012:

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions_en.pdf

New PMDA (Japan) DDI Guidance - English Translation:

​https://www.pmda.go.jp/files/000228122.pdf

MIST:

**New FDA MIST Draft Guidance, March 2020**

https://www.fda.gov/media/72279/download

EMA Guidance for Non-Clinical Studies to Enable Human Clinical Trials

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/non-clinical-guidelines

IND/CTA guidance:

ICH Topic M 3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-3-r2-non-clinical-safety-studies-conduct-human-clinical-trials-marketing-authorization_en.pdf

FDA Guidance for Non-Clinical Studies to Enable Human Clinical Trials

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m3r2-nonclinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorization

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