Regulatory Affairs and Compliance

In Vitro Tests Other Than Dissolution for Bioequivalence Assessment

In Vitro Tests Other Than Dissolution for Bioequivalence Assessment

While dissolution testing is a primary tool for predicting bioequivalence, several other in vitro methods contribute critical insights, especially for BCS Class II/IV drugs or complex formulations. Below is a list 1. Solubility Studies 2. Permeability Assays 3. Precipitation Kinetics and Supersaturation Studies 4. Dynamic Gastrointestinal Simulation Models 5. In Vitro Lipolysis 6. IVIVC 7….

Stability Study of BE Batch

Stability Study of BE Batch

A Frequently Overlooked Yet Crucial Step in Generic Drug Development. When a formulation is finalized and development stability data is already generated, teams often wonder: Q: “If we manufacture a fresh batch for the pivotal bioequivalence (BE) study, do we need to place it on stability again?” Answer: YES. Absolutely. Even if: The pivotal BE…

Viscosity and Bioequivalence of Oral Suspensions
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Viscosity and Bioequivalence of Oral Suspensions

Viscosity plays a particularly critical role—especially when the goal is to demonstrate bioequivalence (BE) with a Reference Listed Drug Key functions of viscosity in suspensions: Bioequivalence Considerations BE studies are conducted to ensure that the rate and extent of drug absorption from a generic product are comparable to that of the RLD. For BCS Class…

Regulatory Foundation | Start with the End in Mind

Regulatory Foundation | Start with the End in Mind

In generic drug development, technical skills alone are not enough. What truly ensures timely success is strong regulatory planning—right from Day 1. Before you even begin pre-formulation work or touch any excipient, you must sit with your Regulatory Affairs team and carefully plan how the product will be registered. This includes understanding FDA requirements, patent…

22 Sections of an ANDA

22 Sections of an ANDA

he 22 sections of an ANDA (Abbreviated New Drug Application) refer to the structured format used for submission to the USFDA, typically following the CTD (Common Technical Document) format. Here’s a simplified list based on how the “Handbook of Pharmaceutical Generic Development” and USFDA expectations outline it: Key Components of the 22 Sections (Non-CTD Format…

Advanced Tips to Perfect Stability Data Submissions for CTD Files

Advanced Tips to Perfect Stability Data Submissions for CTD Files

The Common Technical Document (CTD) is a critical component of regulatory submissions, and presenting precise stability data ensures compliance and accelerates approval timelines. Beyond the usual challenges, there are advanced areas that pharmaceutical companies should address to achieve excellence in their submissions. Key areas to focus on for a superior stability data submission Failure to…

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