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Preparation of Pharmaceutical Development Part for CTD

Name: Preparation of Pharmaceutical Development Part for CTD
Rating: 4.2 (24 reviews)

Pharmaceutical, Pharma, Pharmacy, Drug, Formulation, Process, Manufacturing, Regulatory Affairs, CTD, CMC, R&D, RD

Created byAydan Ozden

Last updated 4/2023

English

English [Auto],

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)

Course content

7 sections • 14 lectures • 3h 20m total length

Introduction5:02
Investigate the pharmaceutical development process, CTD guidelines, and registration dossiers of drug products. Examine API properties, excipients, degradation and stress studies, and manufacturing method development for modern drug products.

Guideline Scope for Pharmaceutical Development13:30
Understand the scope of pharmaceutical development within the CTD framework, including ICH and WHO guidelines, with emphasis on quality module 3 and drug product specifications.
General Definitions for Pharmaceutical Development25:53
Define general terms in pharmaceutical development, including active pharmaceutical ingredient, finished product, control strategy, reference listed drug, and generic and interchangeable products, with emphasis on pharmaceutical and therapeutic equivalence.
Pharmaceutical Development (MODULE 3.2.p.2. in CTD)13:12
Learn how pharmaceutical development studies use a risk-based approach to define quality attributes, DPP, QTPP, CPI, CP, CMA, and a robust control strategy.

Active Product Ingredient for Pharmaceutical Development26:24
Examine key physico chemical properties of active pharmaceutical ingredients—solubility, permeability, biopharmaceutical classification system, particle size, polymorphism, and solid state characterization—and their impact on pharmaceutical development and product performance.
Degredation Studies in Pharmaceutical Development20:33
Explore degradation and compatibility studies in pharmaceutical development, examining how active pharmaceutical ingredients interact with excipients under moderate stress to predict stability and shelf life.

Excipients (Drug Product Ingredients)11:26
Learn how excipients and drug product ingredients influence formulation design, focusing on compatibility with API, degradation impurities, and critical material attributes to ensure reproducible, robust drug products.
Functional Related Characteristics14:45
Examine functional related characteristics of excipients that affect their performance in drug products, including fillers and binders, and how particle size, distribution, solubility, and viscosity influence quality.
Excipients in Pharmaceutical Development3:30
Evaluate excipients' characteristics and justify selections in the drug product registration, ensuring concentrations meet pharmacopeia standards and the FDA inactive ingredients list, with attention to function and stability.

Drug Product in Pharmaceutical Development6:26
Explore drug product development within pharmaceutical development, detailing formulation, manufacturing, critical quality attributes, route of administration, and registration dossier considerations toward batch reproducibility and bioequivalence.
Dissolution Tests28:38
Learn how dissolution tests simulate gastrointestinal conditions to predict drug absorption, understand solubility, diffusion layer, and in vitro–in vivo correlation for immediate and extended release forms.
Dissolution Test in Pharmaceutical Development15:52
Develop dissolution method and solution profile within pharmaceutical development by selecting media, rotation speed, and test conditions; specify immediate release, slowly dissolving, and extended release tablet criteria.

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 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

Who this course is for:

Learners who desire to take a part in Research & Development and Regulatory Affairs Departments in Pharmaceutical Industry
Existing pharma professionals who are looking to progress in their jobs
Anyone who is looking to get entry in pharmaceutical industry

Preparation of Pharmaceutical Development Part for CTD

What you'll learn

Explore related topics

Course content

INTRODUCTION1 lecture • 5min

PHARMACEUTICAL DEVELOPMENT3 lectures • 53min

ACTIVE PRODUCT INGREDIENT2 lectures • 47min

EXCIPIENTS3 lectures • 30min

DRUG PRODUCT3 lectures • 51min

MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENT1 lecture • 8min

CONCLUSION1 lecture • 8min

Requirements

Description

Who this course is for: