Tag: ICH guidelines

International Pharmacovigilance: How Global Safety Monitoring Is Being Harmonized

International Pharmacovigilance: How Global Safety Monitoring Is Being Harmonized
Posted by: Dorian Wellings in: Health and Medicine
4 Dec | 06:51 AM

Global pharmacovigilance harmonization is improving drug safety by aligning reporting standards across countries. Learn how ICH guidelines, AI, and real-world data are reducing delays and saving lives - and where the system still falls short.

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International Pharmacovigilance: How Global Safety Monitoring Is Being Harmonized
International Pharmacovigilance: How Global Safety Monitoring Is Being Harmonized

Global pharmacovigilance harmonization is improving drug safety by aligning reporting standards across countries. Learn how ICH guidelines, AI, and real-world data are reducing delays and saving lives - and where the system still falls short.

Published ON: 4 Dec
What Are Drug Interactions and Why They Matter for Medication Safety
What Are Drug Interactions and Why They Matter for Medication Safety

Drug interactions occur when medications, foods, or health conditions change how a drug works in your body-potentially causing serious harm or reducing effectiveness. Learn what causes them, who's at risk, and how to prevent dangerous combinations.

Published ON: 3 Dec
Replicate Study Designs for Bioequivalence Assessment: Advanced Methods for Highly Variable Drugs
Replicate Study Designs for Bioequivalence Assessment: Advanced Methods for Highly Variable Drugs

Replicate study designs are essential for assessing bioequivalence of highly variable drugs. Learn how full and partial replicate methods reduce sample sizes, meet regulatory standards, and improve generic drug approval rates.

Published ON: 2 Dec
Lithium Carbonate Generics: What You Need to Know About Serum Levels
Lithium Carbonate Generics: What You Need to Know About Serum Levels

Lithium carbonate generics require careful serum level monitoring due to their narrow therapeutic window. Switching between brands can alter blood levels, risking toxicity or relapse. Learn safe targets, testing schedules, and how to avoid dangerous interactions.

Published ON: 1 Dec
Documentation Requirements for Recording Generic Substitution Decisions in Pharmacy Practice
Documentation Requirements for Recording Generic Substitution Decisions in Pharmacy Practice

Learn the essential documentation requirements for recording generic drug substitutions in pharmacy practice. Understand state laws, what to log, common mistakes, and how to avoid errors that impact patient safety.

Published ON: 1 Dec

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