Preparation of Pharmaceutical Development Part for CTD
Pharmaceutical, Pharma, Pharmacy, Drug, Formulation, Process, Manufacturing, Regulatory Affairs, CTD, CMC, R&D, RD
4.43 (22 reviews)
132
students
3.5 hours
content
Apr 2023
last update
$64.99
regular price
What you will learn
Define guideline scope for pharmaceutical development
Define physicochemical properties of active pharmaceutical ingredient (API)
Determine biopharmaceutical classification system (BCS) of active pharmaceutical ingredient (API)
Understand compatibility (degradation) studies and stress (forced degradation) studies in pharmaceutical development
Define excipients and functional related characteristics (FRC) of excipient
Understand requirements for formulation and manufacturing development studies
Evaluate dissolution test studies, discrimitive ability and selectivity of dissolution conditions, specification for IR and ER dosage forms
Understand manufacturing method development
Explain technical definition of Active Pharmaceutical Ingredient (API), Finished Pharmaceutical Product (FPP), and Control Strategy
Explain technical definition of Reference Listed Drug (RLD) and Fixed-Dose Combination Finished Pharmaceutical Product (FDC-FPP)
Explain technical definition of Generic (Multisource) Pharmaceutical Products, Pharmaceutical Alternatives, Pharmaceutical Equivalence, Therapeutic Equivalence
Explain technical definition of Critical Process Parameter (CPP), Critical Quality Attribute (CQA), Quality Target Product Profile (QTPP)
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5022856
udemy ID
12/13/2022
course created date
12/22/2022
course indexed date
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