Search results with tag "New drug substances"
European Medicines Agency
www.ema.europa.euproduction of drug substances and drug products of high quality. This guideline addresses only the marketing approval of new drug products (including combination products) and, where applicable, new drug substances; it does not address drug substances or drug products during the clinical research stages of drug development. This
IMPURITIES IN EW DRUG SUBSTANCES Q3A(R2) - ICH
database.ich.orgintended to apply to new drug substances used during the clinical research stage of development. The following types of drug substances are not covered in this guideline: biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation product and semi-synthetic products derived therefrom, herbal products,
ICH Topic Q 1 A Stability Testing Guidelines: Stability ...
www.pharma.gally.chThe guideline seeks to exemplify the core stability data package required for new drug substances and products. It is not always necessary to follow this when there are scientifically justifiable reasons for using alternative approaches. The guideline provides a general indication on the requirements for stability testing, but leaves ...