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英文字典中文字典相关资料:


  • Guideline on clinical investigation of medicinal products in the . . .
    products), but also updated guidance concerning estimands, requirements for monotherapy indications, studies in children, high strength insulin preparations, definitions of hypoglycaemia and development of oral treatments for patients with type 1 diabetes
  • Insulin Standards - US Pharmacopeia (USP)
    USP maintains 16 insulin monographs, 7 reference standards, and 2 general chapters USP quality standards for insulins cover a broad range of requirements Insulin monographs focus primarily on three areas: Identity Validated tests and physical reference standards to establish the molecular identity of the drug product or drug substance Potency
  • An Overview of Current Regulatory Requirements for Approval of . . .
    As of August 2014, general biosimilar and insulin-specific guidelines are available in 34 countries and two countries regulatory domains, respectively Many guidelines are clearly related to, or partly derived from, the general and insulin-specific European Medicines Agency (EMA) guidelines
  • WHO Guidelines on submission of documentation for the pilot procedure . . .
    These guidelines are intended to assist applicants with the submission of documentation for prequalification of human insulin BTPs, or the corresponding SBPs (based on a RBP approved by a SRA), not registered by an SRA
  • ICH Official web site : ICH
    ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years
  • Insulin - USP–NF
    Acceptance criteria: NLT 26 5 USP Insulin Units mg Resolution: NLT 2 0 between insulin and A-21 on the dried basis; Insulin labeled as purified contains desamido insulin NLT 27 0 USP Insulin Units mg on the dried basis
  • EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION
    As a result, there is now a requirement for a single global standard containing high purity insulin to reflect the status of insulin as a well-characterized, mass-balance assigned molecule [3-4] It is
  • Risk minimisation strategy for high-strength and fixed- combination . . .
    Marketing authorisation holders and applicants are encouraged to use this guidance as a checklist to ensure that the risk of medication errors is addressed consistently for all new high-strength insulins fixed-combination insulins and in line with the regulatory requirements specified in GVP Module V on risk management planning and GVP Module XV
  • Quality Control of Insulins and Biosimilar Insulins - PubMed Central (PMC)
    We take it for granted that the quality control system each manufacturer is required to have is working efficiently, that is, that any batches of insulin that do not fulfill minimum specifications will be quarantined and will not enter the market
  • Clinical Immunogenicity Considerations for Biosimilar and . . .
    The recommendations in this guidance are applicable only to proposed biosimilar and interchangeable insulin products seeking licensure under section 351 (k) of the Public Health Service Act (PHS





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