A biowaiver allows a generic drug to be approved without an in vivo (BE) study based on in vitro dissolution data. This is particularly applicable BCS Class 1 drugs, which have high solubility and high permeability. Biowaiver Justification for BCS Class 1 Drugs To obtain a biowaiver for a BCS Class 1 drug, the following…
There are a list of key pharma databases are providing critical data for drug development, market analysis, regulatory compliance, and competitive intelligence. 1. Drugs@FDA: Provides information on FDA-approved drugs, including labeling, approval history, and therapeutic equivalence. Website: https://www.accessdata.fda.gov/scripts/cder/daf 2. EMA (European Medicines Agency): Offers data on medicines approved in the European Union, including assessment reports…
In formulation development, diluents (or fillers) are often seen as passive ingredients, just there to add bulk, improve compressibility, or adjust dose uniformity. But what if I told you they play critical hidden roles that can make or break a formulation? Here’s a look at some surprising functionalities beyond their textbook definitions: Lactose isn’t just…
Clinical pharmacy is a specialized branch of pharmacy that focuses on patient care and the optimization of medication therapy. It involves working directly with patients and healthcare providers to ensure safe, effective, and appropriate use of medications. Within clinical pharmacy, there are several sub-branches or areas of specialization. Here are the key branches of clinical…
Extended-release injectable formulations are designed to release the active pharmaceutical ingredient (API) at a controlled rate over an extended period, from several hours to weeks. The primary goal of these formulations is to reduce the frequency of administration, minimize drug fluctuations, and maintain therapeutic drug levels, improving patient adherence and clinical efficacy. The development of…
The formulation of biologics presents unique challenges due to their structural complexity and sensitivity to environmental conditions. This review explores critical aspects of biologic formulation, including stability considerations, excipient selection, and delivery systems. Additionally, biopharmaceutical factors such as absorption, distribution, metabolism, and excretion (ADME) of biologics are discussed. Recent advancements in formulation strategies, including novel…
