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provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorization applications and/or Master Files ...
cGMPs serve as the foundation for assessing whether human pharmaceuticals are safe and effective to use. Additionally, they are the main standard regulations which drug manufacturing firms are expected to adhere to. According to cGMP guidelines if any pharmaceutical product passes all specified tests pr...
The mapping was done allowing for maximum 3 mismatches and with other default parameters of BWA. Using samtools29, we then remove the duplicate reads due to PCR amplification during library preparation. For each pool, we retain only high quality (HQ) alignments in sorted BAM files (HQ-BAM) ...
Drug Administration’s (FDA) Guidance for Industry: Computerized Systems Used in Clinical Trials.6,7Principal Investigator (PI) or designated co-Investigator must perform within study review and within site review for GCP and study protocol complia...
This manual is the guideline for freight and customs clearance for the 6th East Asian Games, which includes customs, inspection and quarantine policies, range of exemption, entry port and key dates and contact manner etc. We recommend that NOCs delegations attending the 6th East Asian Games read...
These three residents were on PPIs, although the nonsteroidal anti-inflammatory drug (NSAID) was an “on-demand“ medication. For temporarily prolonged NSAID use, the PPI indication would be adequate, but in the case of a single punctual application of the NSAID, the long-term use of PPIs ...