Generic Product Development Key steps l Step 5: Formulation and process development

                                     

Generic Product Development Key steps

Cont…. 

A typical product development process can be classified as below

Step 1: Discovery (Product Idea)

Step 2: Product Definition

Step 3: Business Case Development

Step 4: Project feasibility

For Step 1 to step 4, refer link 

https://pharmatutor21.blogspot.com/2021/02/generic-product-development-key-steps-l.html

Step 5: Formulation and process development

Step 6: Pilot Bioequivalence Study

Step 7: Submission / Validation Batch Manufacturing

Step 8: Pivotal Bioequivalence Study

Step 9: Dossier Filling

Step 10: Post Dossier Filling

Step 11: Commercial Launch

Step 12: Post approval Changes/ Life Cycle Management

 

 

Step 5: Formulation and process development

A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Therefore, understanding of innovator product is very much essential for the successful development of Generic product. Literature search and understanding of the content with respect to the formulation development and linked with the manufacturing process and bioequivalence study is the prime goal.

        

Innovator product information:

1.     Identification of Innovator product

1.1  Orange book information: Follow the below link

https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

Orange Book: 

·     ·       Approved Drug Products with Therapeutic Equivalence Evaluations     ·       List of drug products approved on the basis of safety and effectiveness by the US FDA under the Federal Food, Drug, and Cosmetic Act.

 

Follow the below steps to Identification of Innovator product

Step-1

Step-2

Step-3

With random search with ‘ABA’ three characters, list stats with Abacavir Sulfate. From the search outcome, it can be learned that

·     -   Abacavir Sulfate is available as Solution and Tablet dosage form

·     -   RLD for both these dosage forms are available, same Applicant holder/innovator

·     -   Generic formulations are available for both Solution and Tablet dosage form

·    -   Route as Oral

 

1.   How to get the RLD/Innovator product information

Information can be obtained from: Drugs@FDA: FDA-Approved Drugs

Link: https://www.accessdata.fda.gov/scripts/cder/daf/

 Step-1

Lets us enter the ‘Abacavir Sulfate’, as an example

 

 Step-2

Step-3

Step-4

 Step-5

Under Review, below mentioned information are available

Step-6

From this site one can get the information

1.   -   Labelling: Also known as Patient information leaflet (PIL)

2.   -   Medical Review

3.    -  Chemistry of the molecule

4.    -  Pharmacological information

5.   -   Microbiological information

6.    -  Clinical Pharmacology and Bioinformatics information

7.     - Administrative information