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Archive for category: Pharmaceutical Safety and Efficacy (PSE)

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Phase 1 Environmental Risk Assessment (ERA)

October 20, 2020/in Pharmaceutical Safety and Efficacy (PSE)/by Roy Jacobs
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Quantitative Structure-Activity Relationship (QSAR) assessment according ICH-M7

October 20, 2020/in Pharmaceutical Safety and Efficacy (PSE)/by Roy Jacobs
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Early Access programs

October 20, 2020/in Pharmaceutical Safety and Efficacy (PSE), Regulatory affairs/by Roy Jacobs
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Health based exposure limits (HBEL)

October 20, 2020/in Pharmaceutical Safety and Efficacy (PSE), Regulatory affairs/by Roy Jacobs
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Clinical and non-clinical sections of the registration dossier

January 1, 2000/in Pharmaceutical Safety and Efficacy (PSE)/by Dave Jacobs
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CRO selection and auditing

January 1, 2000/in Pharmaceutical Safety and Efficacy (PSE)/by Dave Jacobs
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Clinical study related documents

January 1, 2000/in Pharmaceutical Safety and Efficacy (PSE)/by Dave Jacobs
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Advise on study designs (PK, PD, clinical and PASS)

January 1, 2000/in Pharmaceutical Safety and Efficacy (PSE)/by Dave Jacobs
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Medical Review

January 1, 2000/in Pharmaceutical Safety and Efficacy (PSE)/by Dave Jacobs
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Scientific advice

January 1, 2000/in Pharmaceutical Safety and Efficacy (PSE), Regulatory affairs/by Dave Jacobs
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