1. 1/20 2. Drug products for which BA/BE can be waivedBiowaivers for solid oral dosage form based onBCSBiowaiver extensionsData to support biowaivers 2/20 3. Drug Products…

1. Omega-3: Ingredients andStability MonitoringDr. Steve Li, MD, M.Sc. (Clin. Pharm)Director of Laboratory Operations 2. Outline1. Omega-3 and its Product Development2. Quality…

1. VENKATA KUMAR SAHU DEVELOPMENT PROJECTS- AH 2. WHAT IS STABILITY? “the state or quality of being stable” or “continuance without change; permanence” - By Dictionary.com…

SGS Lab Simon S.A. IBCâs 7th International Conference on Stability Testing How to Select, Validate and Report Analytical Test Procedures Used to Monitor Stability Jean Gilliard…

EXTEMPORANEOUS PREPARATION OF PAEDIATRIC ORAL FORMULATIONS Studies conducted in nifedipine powders, capsules and suspensions in a hospital pharmacy Licentiate Thesis in Pharmacy…

Slide 1 Stability Q1(R2) Slide 2 Role Of Stability Safety and efficacy of drug product are established during development via clinical studies Quality is established for…

Stability Q1(R2) Role Of Stability ⢠Safety and efficacy of drug product are established during development via clinical studies ⢠Quality is established for identify,…

Biopharmaceutics Classification System (BCS) Presented By: Nidhi Jasani O9MPH505 Nirma University Guided By: Miss Shital Baria Mrs Renuka Mishra 1 CONTENTS  Introduction…