A generic drug is a drug that is consistent with the original drug (reference drug, RLD) in terms of dosage form, strength, route of administration, quality, curative effect, and use. Generics play a key role in the health care system, accounting for more than 50% of all prescriptions. Generic drugs are approved on the basis […]
The Role Of Originator Drug Characterization In Generic Drug Development Read More »
The research and development of polymorphic forms of drugs has always been a research hotspot in the field of biopharmaceuticals. Different crystal states of drugs will have an important impact on drug solubility, dissolution rate, bioavailability and other aspects. It is also a key link in the quality and safety control of drug production. It
Advances In Research On Polymorphic Forms Of Solid Drugs Read More »
Oral solid preparations of drugs are widely used clinically, and the attention paid to their quality and safety is lower than that of other dosage forms. The safety of oral solid preparations cannot be ignored. The 2010 version of drug GMP puts forward the concept of quality risk management. How to implement quality risk management
Quality Risk Management Of Oral Solid Dosage Form GMP Management Read More »
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