A substance specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime. Reference EMA December 2012 Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.
Glossary
Permitted Daily Exposure (PDE)
03.25.13
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Promotions & Moves
Akebia Therapeutics Names CMO
Jain to lead clinical development of the company’s HIF pipeline
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Breaking News | Fill/Finish | Industry News | Packaging & Tracking | Vials
HCPC Study Reveals Degradation Risk
Evaluates conventional packaging vs high barrier unit dose blisters
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APIs | Cleaning Validation | Clinical Trial Materials | Clinical Trials | Extractables and Leachables | Facilities | GMPs/GCPs | Inspections | Methods Development | Process Development | QA/QC | Regulatory Affairs | Risk Management | Toxicology | Validation
The New EU GMPs for Cross Contamination
Industry needs to prepare in order to comply with the updates.Stephanie Wilkins , PharmaConsult US, Inc.
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Cleaning Validation | Clinical Trials | Cytotoxics and High Potency Manufacturing | GMPs/GCPs | Inspections | Laboratory Testing | Process Validation | Regulatory Affairs | Risk Management | Validation
High Potency Regulations
Uncertainty remains in the quest to define certain productsStephanie Wilkins, PharmaConsult US, Inc.
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PDE
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