1. Introduction Solid dosage forms are the most frequently used drug delivery systems (DDS) for oral administration. They differ drastically in size and number of units administered as a single dose, including both single-unit dosage form (SUDF) and multiple-unit dosage form (MUDF). Multi-unit pellet system (MUPS) is one of the most popular MUDFs because of
1. Common definition(s) Primary Standard (primary standard): A standard of the highest purity, having the important properties fully validated and widely recognized, of suitable quality under specified conditions, and having a recognized value acceptable without having to compare it with another standard. Reference standards: including pharmacopoeial standards and non-pharmacopoeia standards (basic standards provided by the
1. Introduction Mean Kinetic Temperature (MKT) is used in the pharmaceutical industry to evaluate the effect fluctuating temperatures have over time on the efficacy and safety of a drug product. In 1971, J.D. Haynes calculated a “Virtual Temperature” to predict product expiration when considering temperature variability in a given region. The formula uses the Arrhenius
When medical device manufacturers consider placing devices on the market, they face the challenge of understanding the regulatory environment in different jurisdictions and the regulatory requirements that apply to them and their machines. As medical device regulators evolve their regulatory frameworks in a particular jurisdiction, they look for solutions to challenges they face from other
At present, technology transfer in general, and transfer analytical method, in particular, is a problems of great concern for factories or laboratories. The transfer of analytical methods to improve product quality as well as bring domestic technology to ensure fast and sustainable development. Before an analytical method is transferred, it should be properly developed and
An orphan drug designation is a status delivered by FDA (US) or EMA (Europe) for pharmaceutical drug that has been developed specifically to treat an ultra-rare disease (affecting less than 200,000 patients in the United States and/or 500,000 patients in the European Union). What does it mean to be granted orphan drug designation? Orphan drug
Tổng quát Patient safety is the primary objective of the Pharmaceutical Quality System (PQS), Manufacturing Authorization holder is required to manufacture safe and effective medicinal products in accordance with the Marketing Authorisation. To ensure this, the PQS is utilized. Adequate resources (locations, equipment, and employees), a sound quality policy with appropriate quality targets, and documentation
1. Hoàn cảnh ra đời của GMP Hoa Kỳ vào những năm đầu tiên của thế kỷ 20 khi đó các ngành công nghiệp vẫn còn sơ khai (nước đá được sử dụng để làm lạnh, và sữa cũng chưa được tiệt trùng). Các loại hóa chất bảo quản và phụ gia thực phẩm được
Bài viết dưới đây chỉ trích dẫn, diễn dịch một phần nội dung (không bao gồm toàn bộ thông tin) của Nghị định 54/2017/NĐ-CP và Nghị định 155/2018/NĐ-CP, nhằm mục đích tóm tắt một số thông tin chính giúp hiểu cơ bản về các biện pháp quản lý giá thuốc tại Việt Nam: 1. Kê
