In-vitro Studies for Solid Oral Dosage Forms in Pharma

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Aydan Ozden

3:54:37

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1. Giris

1.1 1 Introductıon.pdf

1. Introduction.mp4

04:25

2. In-vitro & In-vivo Studies for Drug Product

1. Reference Listed Drug (RLD) & Generic Drug.mp4

10:28

2. Drug Development.mp4

12:34

3. In-vitro & In-vivo Performance of Drug Product.mp4

15:01

3. Solubility

1. Solubility of Drug Product.mp4

09:25

2. Solubility & Dissolution.mp4

12:08

4. Dissolution & Dissolution Selectivity

1. Dissolution-1 (Dissolution Instrument).mp4

04:10

2. Dissolution-2 (Variations on CMA, CPP, Formulation Component & Dissolution Sele.mp4

07:15

3. Dissolution-3 (Particle Size Distribution & Dissolution Selectivity).mp4

04:43

4. Dissolution-4 (Polymorphic Structure & Dissolution Selectivity).mp4

04:40

5. Dissolution-5 (Excipients Composition & Dissolution Selectivity).mp4

03:37

6. Dissolution-6 (Critical Process Parameters & Dissolution Selectivity).mp4

03:13

5. Dissolution Test as a Tool

1. Dissolution Method as a Formulation Development Tool.mp4

05:15

2. Dissolution Method as a Quality Control Tool-1.mp4

06:24

3. Dissolution Method as a Quality Control Tool-2.mp4

05:31

6. Dissolution Test Method

1.1 2 USP CHAPTER 711.pdf

1.2 3 USP CHAPTER 724.pdf

1.3 4 USP CHAPTER 1088.pdf

1.4 5 USP CHAPTER 1090.pdf

1.5 6 1.pdf

1.6 6 USP CHAPTER 1092.pdf

1. Dissolution Apparatus.mp4

09:41

2.1 6 2.pdf

2. Stirring Rate.mp4

03:48

3.1 6 3.pdf

3. Dissolution Volume & Sink Condition.mp4

04:58

4.1 6 4.pdf

4. Dissolution Media (Medium) & Surfactant Usage.mp4

16:36

5.1 6 5.pdf

5. Dissolution Sampling & Sampling Point & Sampling Apparatus.mp4

10:23

6.1 6 6.pdf

6. Critical Issues for Dissolution.mp4

10:55

7. Evaluation of Dissolution Test Results

1. Dissolution Results & Similarity Factor.mp4

10:05

8. Selectivity of Dissolution Method

1.1 8 1.pdf

1. Selectivity of Dissolution Method-1.mp4

03:50

2.1 8 2.pdf

2. Selectivity of Dissolution Method-2.mp4

04:24

3.1 8 3.pdf

3. Selectivity of Dissolution Method-3.mp4

03:57

4.1 8 4.pdf

4. Selectivity of Dissolution Method-4.mp4

03:56

9. Dissolution in Pharmaceutical Development

1.1 9 1.pdf

1. Dissolution in Pharmaceutical Development.mp4

13:05

2.1 10 1.pdf

2. Discrimitive Dissolution Method Development.mp4

09:01

10. Dissolution in ICH

1.1 11 1.pdf

1. Dissolution in ICH.mp4

05:53

2.1 11 2.pdf

2. Dissolution for Immediate Release Tablet.mp4

07:42

11. Conclusion

1. Conclusion.mp4

07:34

Description

Explore in-vitro studies and learn dissolution analysis techniques for drug development in R&D & quality control in QC!

What You'll Learn?

Define reference listed drug (RLD) & generic drug and their development processes
Understand importance of in-vitro & In-vivo studies for drug development processes
Understand importance of in-vitro & In-vivo studies for drug development processes
Learn dissolution theory and dissolution instrument
Evaluate dissolution selectivity for variations related with material, formulation and process
Learn dissolution method as a formulation development tool
Learn dissolution method as a quality control tool
Evaluate dissolution results and calculate similarity factor
Define dissolution apparatus, stirring rate, dissolution volume, dissolution media, dissolution sampling
Understand importance of dissolution test in pharmaceutical development
Learn strategy for discrimitive dissolution method development
Define dissolution specification and acceptance criteria for immediate release tablet
Define dissolution specification and acceptance criteria for extended release tablet

Who is this for?

Learners who desire to take a part in Pharmaceutical Industry

Existing pharma professionals who are looking to progress in their jobs

Anyone who is looking to get entry in pharmaceutical industry

What You Need to Know?

Require mobile/tablet/laptop/personal computer with internet

To be student, graduate and/or professional in related disciplines

More details

Description
New Drug Application (NDA) and Abbreviated New Drug Application (ANDA)Â submissions contain in-vivo (bioavailability or bioequivalence data) and in-vitro dissolution data.
In-vivo and in-vitro dissolution data, together with chemistry, manufacturing, and controls (CMC) data, are so important to characterize the quality and performance of the drug product.

In-vitro dissolution methods are developed to evaluate the in-vivo bioperformance of solid oral dosage forms.
In-vitro dissolution methods are quality control tests to ensure the consistency of product manufacturing and the bioperformance of solid oral dosage forms.
Dissolution test is the simulation of in-vivo conditions in the in-vitro environment.
Dissolution test is so important control tool because it is used for evaluating of in-vivo performance of drug product without any in-vivo performance.
Dissolution test is developed and performed in laboratory conditions (in-vitro conditions). Dissolution test is kind of simulation in lab conditions. Dissolution test is usefull to foresee the performance of drug products in biological environment (in-vivo conditions).
In the scope of course all technical details and requirements of dissolution analysis have been discussed.

IN-VITRO STUDIES FOR SOLID ORAL DOSAGE FORMS IN PHARMA
1 Introduction
2 In-vitro & In-vivo Studies for Drug Product
2.1. Reference Listed Drug (RLD) & Generic Drug
2.2. Drug Development
2.3. In-vitro & In-vivo Performance of Drug Product
3 Solubility
3.1. Solubility of Drug Product
3.2. Solubility & Dissolution
4 Dissolution & Dissolution Selectivity
4.1. Dissolution-1 (Dissolution Instrument)
4.2. Dissolution-2 (Variations on CMA, CPP, Formulation Component & Dissolution Selectivity)
4.3. Dissolution-3 (Particle Size Distribution & Dissolution Selectivity)
4.4. Dissolution-4 (Polymorphic Structure & Dissolution Selectivity)
4.5. Dissolution-5 (Excipients Composition & Dissolution Selectivity)
4.6. Dissolution-6 (Critical Process Parameters & Dissolution Selectivity)
5 Dissolution Test as a Tool
5.1. Dissolution Method as a Formulation Development Tool
5.2. Dissolution Method as a Quality Control Tool-1
5.3. Dissolution Method as a Quality Control Tool-2
6 Dissolution Test Method
6.1. Dissolution Apparatus
6.2. Stirring Rate
6.3. Dissolution Volume & Sink Condition
6.4. Dissolution Media (Medium) & Surfactant Usage
6.5. Dissolution Sampling & Sampling Point & Sampling Apparatus
6.6. Critical Issues for Dissolution
7 Evaluation of Dissolution Test Results
7.1. Dissolution Results & Similarity Factor
8 Selectivity of Dissolution Method
8.1. Selectivity of Dissolution Method-1
8.2. Selectivity of Dissolution Method-2
8.3. Selectivity of Dissolution Method-3
8.4. Selectivity of Dissolution Method-4
9 Dissolution in Pharmaceutical Development
9.1. Dissolution in Pharmaceutical Development
9.2. Discrimitive Dissolution Method Development
10 Dissolution in ICH
10.1. Dissolution in ICH
10.2. Dissolution for Immediate Release Tablet
10.3. Dissolution for Extended Release Tablet
11 Conclusion
Who this course is for:
Learners who desire to take a part in Pharmaceutical Industry
Existing pharma professionals who are looking to progress in their jobs
Anyone who is looking to get entry in pharmaceutical industry

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She is Aydan OZDEN. She is working as R&D Formulation Development Scientist at Pharmaceutical Company. She hold a Bachelor of Chemistry and a Master’s degree in Organic Chemistry. She offer proficiency in pharmaceutical Quality and Research and Development including but not limited to drug formulation development, drug manufacturing process, and associated scientific and regulatory elements. She has an extensive knowledge in pharmaceutical R&D, specially in the drug formulation development, drug manufacturing process and associated scientific and regulatory elements with 9 years experience. She also gained strong theoretical and practical background in conducting preformulation studies, formulation development, process optimization and scale up of generic drug products while knowing and applying main principles of medicinal chemistry.She has five Udemy courses presented below.- Quality in Pharmaceutical Industry (GMP & GLP & GHP): This course is strongly recommended for learners who interest pharmaceutical industry and desire to take a part in Quality, Production, Technology Transfer and Research&Development Departments.- Pharmaceutical Dosage Forms & Basics of Pharma Industry: This course is strongly recommended for learners who interest pharmaceutical industry, especially for fresh graduate, and desire to take a part in Quality, Production, Technology Transfer, Research & Development Departments and Business Development.- Pharmaceutical Manufacturing & Technology (GRANULATION): This course is strongly recommended for learners who interest pharmaceutical drug manufacturing and desire to take a part in Quality Assurance, Production, Technology Transfer and Research & Development Departments.- Pharmaceutical Manufacturing & Technology (COATING): This course is strongly recommended for learners who interest pharmaceutical drug manufacturing and desire to take a part in Quality Assurance, Production, Technology Transfer and Research & Development Departments.- Preformulation Studies for Pharmaceutical Industry: This course is strongly recommended for learners who interest physicochemical properties of drug product and desire to take a part in Research & Development Department.- Preparation of Pharmaceutical Development Part for CTD: This course is strongly recommended for learners who interest pharmaceutical development / drug development and desire to take a part in Research & Development, Technology Transfer and Regulatory Affairs Departments.

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