What you'll 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)
Requirements
Require mobile/tablet/laptop/personal computer with internet
To be student, graduate and/or professional in related disciplines
Description
The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The pharmaceutical development studies and the manufacture of primary batches are essential elements for the science and risk-based approach to establish the critical quality attributes (CQAs) of the finished pharmaceutical product and the critical process parameters (CPPs) of the manufacturing process. The information and knowledge gained from pharmaceutical development studies provide scientific understanding to support the establishment of specifications and manufacturing controls. This course provides informations, evaluations, and explanations on the contents of a pharmaceutical development plan for generic (multisource) pharmaceutical products for anyone who is looking to get entry in pharmaceutical industry and existing pharma professionals who are looking to progress in their jobs. The pharmaceutical development section in registration product dossier should also contain information on the development studies conducted to establish that the dosage form, formulation, and manufacturing process. These studies have been also explained and detailed in the scope of this Pharmaceutical Development course.COURSE CONTENT1. GUIDELINE SCOPE FOR PHARMACEUTICAL DEVELOPMENT -CTD (Common Technical Document) -ICH Q8 Pharmaceutical Development -WHO, Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products -Scope of Quality Modül 3.2.P.2.2. GENERAL DEFINITIONS FOR PHARMACEUTICAL DEVELOPMENT -Active Pharmaceutical Ingredient (API) -Finished Pharmaceutical Product (FPP) -Control Strategy -Reference Listed Drug (RLD) -Fixed-Dose Combination Finished Pharmaceutical Product (FDC-FPP) -Generic (Multisource) Pharmaceutical Products -Pharmaceutical Alternatives -Pharmaceutical Equivalence -Therapeutic Equivalence -Critical Process Parameter (CPP) -Critical Quality Attribute (CQA) -Quality Target Product Profile (QTPP) 3. PHARMACEUTICAL DEVELOPMENT 3.2.p.2.4. ACTIVE PRODUCT INGREDIENT FOR PHARMACEUTICAL DEVELOPMENT -Physicochemical Properties of Active Product Ingredient -Solubility -Permeability -Biopharmaceutical Classification System (BCS) Classification -Particle Size Distribution (PSD) -Polymorphic Structure -Solid State Characterization5. DEGRADATION STUDIES IN PHARMACEUTICAL DEVELOPMENT -Compatibility (Degradation) Studies -Stress Factors in the Compatiblity (Degradation) Studies -Compatibility (Degradation) Studies in Pharmaceutical Development -Stress (Forced Degradation) Studies -Comparison of Compatibility (Degredation) Studies and Stress (Forced Degradation) Studies 6. EXCIPIENTS7. FUNCTIONAL RELATED CHARACTERISTICS -Definition of Functional Related Characteristics -Functional Related Characteristics for Fillers -Functional Related Characteristics for Binders -Functional Related Characteristics for Disintegrants -Functional Related Characteristics of Polyvinylpyrolidone (PVP) -Evaluation of Functional Related Characteristics of Disintegrants8. EXCIPIENTS IN PHARMACEUTICAL DEVELOPMENT 9. DRUG PRODUCT IN PHARMACEUTICAL DEVELOPMENT 10. DISSOLUTION -Solubility -Solubility & Dissolution -Dissolution Test (In-vitro & In-vivo Correlation) -Definition of Dissolution Test -Aims of Dissolution Test -Selectivity of Dissolution Method -Dissolution in ICH Q6A -Dissolution in ICH Q6A – Immediate Release -Dissolution in ICH Q6A – Extended Release11. DISSOLUTION IN PHARMACEUTICAL DEVELOPMENT -Dissolution in Pharmaceutical Development -Dissolution Specification for IR Tablet -Dissolution Specification for Slowly Dissolving IR Tablet -Dissolution Specification for ER Tablet12. MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENT -Manufacturing Method Selection -Manufacturing Method Development
Overview
Section 1: Introduction
Lecture 1 Introduction
Section 2: PHARMACEUTICAL DEVELOPMENT
Lecture 2 GUIDELINE SCOPE FOR PHARMACEUTICAL DEVELOPMENT
Lecture 3 GENERAL DEFINITIONS FOR PHARMACEUTICAL DEVELOPMENT
Lecture 4 PHARMACEUTICAL DEVELOPMENT (MODULE 3.2.p.2. in CTD)
Section 3: ACTIVE PRODUCT INGREDIENT
Lecture 5 ACTIVE PRODUCT INGREDIENT FOR PHARMACEUTICAL DEVELOPMENT
Lecture 6 DEGRADATION STUDIES IN PHARMACEUTICAL DEVELOPMENT
Section 4: EXCIPIENTS
Lecture 7 EXCIPIENTS (DRUG PRODUCT INGREDIENTS)
Lecture 8 FUNCTIONAL RELATED CHARACTERISTICS
Lecture 9 EXCIPIENTS IN PHARMACEUTICAL DEVELOPMENT
Section 5: DRUG PRODUCT
Lecture 10 DRUG PRODUCT IN PHARMACEUTICAL DEVELOPMENT
Lecture 11 DISSOLUTION TEST
Lecture 12 DISSOLUTION TEST IN PHARMACEUTICAL DEVELOPMENT
Section 6: MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENT
Lecture 13 MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENT
Section 7: CONCLUSION
Lecture 14 CONGRATULATIONS! & THANK YOU!
Anyone who is looking to get entry in pharmaceutical industry,Existing pharma professionals who are looking to progress in their jobs



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