Biowaiver for Topical Dosage Forms

Biowaiver for Topical Dosage Forms

A Biowaiver for a topical dosage form refers to regulatory approval for marketing a generic topical product without conducting in vivo bioequivalence (BE) studies. Instead, equivalence is demonstrated using in vitro methods and other scientific justifications. Key Considerations for Biowaiver of Topical Dosage Forms Regulatory agencies such as USFDA, EMA, and WHO provide guidelines for…

Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies

Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies

When BE is demonstrated for one strength of a drug product, regulatory agencies allow a biowaiver for additional strengths under certain conditions. The key criteria vary across USFDA, EMA, WHO, MHRA, TGA, and CDSCO but are largely aligned on fundamental principles. USFDA Biowaiver Criteria Biowaiver is allowed for additional strengths if: EMA Biowaiver Criteria Follows…

20 Essential Databases for Industrial Pharmacists

20 Essential Databases for Industrial Pharmacists

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…

The Hidden Superpowers of Pharmaceutical Diluents

The Hidden Superpowers of Pharmaceutical Diluents

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…

Branches of Clinical Pharmacy
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Branches of Clinical Pharmacy

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…

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