AI Applications in Generic Pharmaceuticals

-

 AI is becoming an essential tool in the development of generic pharmaceuticals and in gaining approval from regulatory bodies.


AI Applications in Generic Pharmaceuticals:

 1. Formulation Development: AI helps optimize excipient and API interactions.
 2. Bioequivalence Studies: AI predicts bioequivalence and streamlines study designs.
 3. Process Optimization: AI enhances manufacturing efficiency and scale-up.
 4. Regulatory Submission: AI automates ANDA submission preparation, increasing speed and accuracy.
 5. Post-Market Monitoring: AI tracks safety data and ensures long-term drug safety.
 6. Patent Expiry: AI predicts patent expirations and assists in planning market entry.

Comments

Post a Comment

Popular posts from this blog

Top 10 Pharma Industry Trends & Innovations in 2021

-
Image
                                          Top 10 Pharma Industry Trends & Innovations in 2021 The COVID pandemic has forced all companies to rethink many aspects of their business, including manufacturing and the same holds true for pharma companies. The pandemic also highlights the need for improving the speed and accuracy of finding and mass-producing novel drugs, treatment methods, and vaccines to respond to such large-scale and high-pressure demand. Below are most relevant solution  1. Artificial Intelligence and Machine Learning The use of artificial intelligence and machine learning is accelerating the drug discovery and development processes. Pharma industries are exploring the use of these technologies to address the various challenges, such as automation and optimization of the manufacturing processes, as well as designing effective marketi...
Read more

Nitrosamine Impurities: API & Pharmaceutical Products

-
Image
                                     Nitrosamine Impurities: API & Pharmaceutical Products The Sartans case substantiates the necessity for the pharmaceutical industry to improve the standards on application of risks management tools, particularly regarding post approval activities. The case also showed some of the potential risks associated with the lack of transparency between MAHs, API manufacturers, and others over patient safety and the shift required to increase transparency through revisions of the regulatory framework whilst ensuring safeguarding of confidential information.   Medicine regulatory authorities were alerted of the presence of the nitrosamine impurity, N-nitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is an Angiotensin II Receptor Blocker (ARB) belonging to a class of products commonly referred to as sartans. ...
Read more

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

-
Image
                                               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, safet...
Read more