August 8th 2024
Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
Gauging Opportunities in the Biosimilars Market
April 8th 2009Follow-on biologics or biosimilars offer a niche growth market for the pharmaceutical industry. As the process for establishing a regulatory pathway for biosimilars is debated, companies, including Big Pharma, are positioning themselves to gain this piece of the pharmaceutical pie.
Influence of Superdisintegrants on the Rate of Drug Dissolution from Oral Solid Dosage Forms
April 1st 2009The authors examine common superdisintegrants (i.e., crospovidone Type A, crospovidone Type B, croscarmellose sodium, and sodium starch glycolate) with a set of poorly soluble drug actives and evaluate in vitro drug dissolution.
USP and NICPBP Sign Memorandum of Understanding
March 19th 2009The US Pharmacopeial Convention (USP) and the National Institute for the Control of Pharmaceutical Biological Products (NICPBP), China's agency for overseeing the quality of large- and small-molecule drugs, signed a memorandum of understanding (MOU) to bolster the quality of medicines in China and in the countries that buy Chinese drug products, including the United States.
SOCMA Comments on Congressional Activity on IST
March 12th 2009The Synthetic Organic Chemical Manufacturers Association (SOCMA) said last week that Congress is likely to the include inherently safe technology (IST) measures in proposed chemical site-security legislation that is likely to be introduced in late winter or early spring.