Preparation of Pharmaceutical Development Part for CTD

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 Preparation of Pharmaceutical Development Part for CTD course.

COURSE CONTENT

1. 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 Characterization

5. 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. EXCIPIENTS

7. 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 Disintegrants

8. 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 Release

11. DISSOLUTION IN PHARMACEUTICAL  DEVELOPMENT   

-Dissolution in Pharmaceutical Development     

-Dissolution Specification for IR Tablet   

-Dissolution Specification for Slowly Dissolving IR Tablet   

-Dissolution Specification for ER Tablet

12. MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENT   

-Manufacturing Method Selection   

-Manufacturing Method Development