oaxino Posted December 20, 2022 Report Share Posted December 20, 2022 Published 12/2022MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHzLanguage: English | Size: 1.04 GB | Duration: 3h 13mPharmaceutical Development, Pharmacy, Chemistry, Formulation, Process, Manufacturing, Regulatory Affairs, CTD, CMCWhat you'll learnDefine guideline scope for pharmaceutical developmentDefine 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 developmentDefine excipients and functional related characteristics (FRC) of excipientUnderstand requirements for formulation and manufacturing development studiesEvaluate dissolution test studies, discrimitive ability and selectivity of dissolution conditions, specification for IR and ER dosage formsUnderstand manufacturing method developmentExplain technical definition of Active Pharmaceutical Ingredient (API), Finished Pharmaceutical Product (FPP), and Control StrategyExplain 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 EquivalenceExplain technical definition of Critical Process Parameter (CPP), Critical Quality Attribute (CQA), Quality Target Product Profile (QTPP)RequirementsRequire mobile/tablet/laptop/personal computer with internetTo be student, graduate and/or professional in related disciplinesDescriptionThe 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 DevelopmentOverviewSection 1: IntroductionLecture 1 IntroductionSection 2: PHARMACEUTICAL DEVELOPMENTLecture 2 GUIDELINE SCOPE FOR PHARMACEUTICAL DEVELOPMENTLecture 3 GENERAL DEFINITIONS FOR PHARMACEUTICAL DEVELOPMENTLecture 4 PHARMACEUTICAL DEVELOPMENT (MODULE 3.2.p.2. in CTD)Section 3: ACTIVE PRODUCT INGREDIENTLecture 5 ACTIVE PRODUCT INGREDIENT FOR PHARMACEUTICAL DEVELOPMENTLecture 6 DEGRADATION STUDIES IN PHARMACEUTICAL DEVELOPMENTSection 4: EXCIPIENTSLecture 7 EXCIPIENTS (DRUG PRODUCT INGREDIENTS)Lecture 8 FUNCTIONAL RELATED CHARACTERISTICSLecture 9 EXCIPIENTS IN PHARMACEUTICAL DEVELOPMENTSection 5: DRUG PRODUCTLecture 10 DRUG PRODUCT IN PHARMACEUTICAL DEVELOPMENTLecture 11 DISSOLUTION TESTLecture 12 DISSOLUTION TEST IN PHARMACEUTICAL DEVELOPMENTSection 6: MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENTLecture 13 MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENTSection 7: CONCLUSIONLecture 14 CONGRATULATIONS! & THANK YOU!Anyone who is looking to get entry in pharmaceutical industry,Existing pharma professionals who are looking to progress in their jobsDownload linkrapidgator.net:https://rapidgator.net/file/d721e9b43812c6eec66e74901c0bd6a1/namtq.Pharmaceutical.Development.part1.rar.htmlhttps://rapidgator.net/file/bfadffe3a497325feaba3e00171b0686/namtq.Pharmaceutical.Development.part2.rar.htmluploadgig.com:https://uploadgig.com/file/download/D396ae7cb8ea67dd/namtq.Pharmaceutical.Development.part1.rarhttps://uploadgig.com/file/download/6d8948B992A93fae/namtq.Pharmaceutical.Development.part2.rarnitroflare.com:https://nitroflare.com/view/D30C4EC9751CBAF/namtq.Pharmaceutical.Development.part1.rarhttps://nitroflare.com/view/0ABAB04093F2155/namtq.Pharmaceutical.Development.part2.rar1dl.net:https://1dl.net/tqsw4jnhgkqk/namtq.Pharmaceutical.Development.part1.rarhttps://1dl.net/4byetuh5ecyg/namtq.Pharmaceutical.Development.part2.rar Link to comment Share on other sites More sharing options...
Recommended Posts
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!
Register a new accountSign in
Already have an account? Sign in here.
Sign In Now