The continuing battle over baby-milk formula

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...

Microbial fermentation is central to food biotechnology, enhancing flavor, texture, preservation, and stability. Fermentative microorganisms metabolize carbohydrates into organic acids, alcohols, and other metabolites that inhibit spoilage organisms and improve digestibility while contributing distinctive sensory qualities.In baking, amylases naturally present in flour hydrolyze starch into monosaccharides such as glucose, which Saccharomyces cerevisiae ferments anaerobically. Through...

The human microbiota begins developing at birth and undergoes continual change as we age. Infancy marks a critical period of microbial sensitivity, offering a “window of opportunity” during which beneficial microbes help mature the immune system. By age three, children typically develop a more stable and diverse microbial community. Newborns acquire microbes from their immediate environment; vaginal delivery favors maternal vaginal microbes, while cesarean births favor microbes from the skin...

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...