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41. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

nlm:nlmuid-101734088-pdf

42. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

nlm:nlmuid-101734090-pdf

43. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff

nlm:nlmuid-101734092-pdf

44. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

nlm:nlmuid-101734132-pdf

50. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers

nlm:nlmuid-101734186-pdf