- NLM Digital Collections - Bioanalytical method validationPublication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018... the failed and accepted runs for each study. Clinical Study XXYY-0032456 Batch number Results Comments Analytical Dates of within (Accepted ...
- NLM Digital Collections - Findings from provider organizations using patient registries ; addendum to using ...Publication: [Oakland, Calif.] : California HealthCare Foundation, [2004]... for many conditions from Programs to Go. A clinical coordinator in each clinic batches visit planners with handwritten documentation, reviews them for ...
- NLM Digital Collections - Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018... generally obtained from: (1) batches used in pivotal clinical and/or BA/BE studies, (2) batches used as stability registration batches, and (3) batches ...
- NLM Digital Collections - Plasma substitutes, except those derived from human blood, 1940-1951 : an annotated ...Publication: Washington, D.C. : Army Medical Library, [1951]... tion in sufficiently large quantity to permit adequate clinical trial on a uniform batch have been investigated. A satisfactory process has been ...
- NLM Digital Collections - Chemistry, manufacturing, and control (CMC) information for human gene therapy ...Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020... stage INDs, this may include toxicology lots, developmental batches, engineering runs, or a single manufacturing run for clinical grade material. We recommend that you gain adequate ...
- ... Hepatitis B surface antigen is mostly done by clinical laboratories in large batches at relatively low cost. To compete for this business, the Company is designing a special clinical pack that will contain the essential Golden Test ~ ...
- NLM Digital Collections - Development of abbreviated new drug applications during the COVID-19 pandemic : questions and ...Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, September 8, 2021... product-specific guidance, the same unexpired test product batch should be used where possible for all three studies (i.e., in vivo comparative clinical endpoint BE study, in vivo PK BE study, ...
- NLM Digital Collections - M4E(R2) : the CTD--efficacyPublication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017... marketed drug product • The drug product used in clinical studies supporting effectiveness and the drug product used in stability batches • Similar drug products from different manufacturers 5.3. ...
- NLM Digital Collections - Letter from Memorial Sloan-Kettering Cancer Center to Mary LaskerPublication: Produced: 29 November 1977... human carriers of the Hepatitis B antigen. Such batches of interferon would not be certifiable for clinical use but could be used for laboratory studies. ...
- NLM Digital Collections - Liposome drug products : chemistry, manufacturing, and controls : human pharmacokinetics and ....Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018... supported by development data, including test results on batches of liposome drug used in pivotal clinical trials or bioequivalence studies. f. Particle size (i. ...
735 results