What you'll learn
Define reference listed drug (RLD) & generic drug and their development processes
Understand importance of in-vitro & In-vivo studies for drug development processes
Understand importance of in-vitro & In-vivo studies for drug development processes
Learn dissolution theory and dissolution instrument
Evaluate dissolution selectivity for variations related with material, formulation and process
Learn dissolution method as a formulation development tool
Learn dissolution method as a quality control tool
Evaluate dissolution results and calculate similarity factor
Define dissolution apparatus, stirring rate, dissolution volume, dissolution media, dissolution sampling
Understand importance of dissolution test in pharmaceutical development
Learn strategy for discrimitive dissolution method development
Define dissolution specification and acceptance criteria for immediate release tablet
Define dissolution specification and acceptance criteria for extended release tablet
Requirements
Require mobile/tablet/laptop/personal computer with internet
To be student, graduate and/or professional in related disciplines
Description
IN-VITRO STUDIES FOR SOLID ORAL DOSAGE FORMS IN PHARMA 1 Introduction 2 In-vitro & In-vivo Studies for Drug Product 2.1. Reference Listed Drug (RLD) & Generic Drug 2.2. Drug Development 2.3. In-vitro & In-vivo Performance of Drug Product 3 Solubility 3.1. Solubility of Drug Product 3.2. Solubility & Dissolution 4 Dissolution & Dissolution Selectivity 4.1. Dissolution-1 (Dissolution Instrument) 4.2. Dissolution-2 (Variations on CMA, CPP, Formulation Component & Dissolution Selectivity) 4.3. Dissolution-3 (Particle Size Distribution & Dissolution Selectivity) 4.4. Dissolution-4 (Polymorphic Structure & Dissolution Selectivity) 4.5. Dissolution-5 (Excipients Composition & Dissolution Selectivity) 4.6. Dissolution-6 (Critical Process Parameters & Dissolution Selectivity) 5 Dissolution Test as a Tool 5.1. Dissolution Method as a Formulation Development Tool 5.2. Dissolution Method as a Quality Control Tool-1 5.3. Dissolution Method as a Quality Control Tool-2 6 Dissolution Test Method 6.1. Dissolution Apparatus 6.2. Stirring Rate 6.3. Dissolution Volume & Sink Condition 6.4. Dissolution Media (Medium) & Surfactant Usage 6.5. Dissolution Sampling & Sampling Point & Sampling Apparatus 6.6. Critical Issues for Dissolution 7 Evaluation of Dissolution Test Results 7.1. Dissolution Results & Similarity Factor 8 Selectivity of Dissolution Method 8.1. Selectivity of Dissolution Method-1 8.2. Selectivity of Dissolution Method-2 8.3. Selectivity of Dissolution Method-3 8.4. Selectivity of Dissolution Method-4 9 Dissolution in Pharmaceutical Development 9.1. Dissolution in Pharmaceutical Development 9.2. Discrimitive Dissolution Method Development 10 Dissolution in ICH 10.1. Dissolution in ICH 10.2. Dissolution for Immediate Release Tablet 10.3. Dissolution for Extended Release Tablet 11 Conclusion
Who this course is for
Learners who desire to take a part in Pharmaceutical Industry
Existing pharma professionals who are looking to progress in their jobs
Anyone who is looking to get entry in pharmaceutical industry



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rapidgator.net:

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