Pharmaceutical Development

Published 12/2022MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHzLanguage: English | Size: 1.04 GB | Duration: 3h 13m

Pharmaceutical Development, Pharmacy, Chemistry, Formulation, Process, Manufacturing, Regulatory Affairs, CTD, CMC

What you'll learn

Define guideline scope for pharmaceutical development

Define physicochal properties of active pharmaceutical ingredient (API)

Detee 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 Modul 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 -Physicochal 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)