Guidance for industry [[electronic resource] ] : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region . Annex 1 Residue on ignition/sulphated ash general chapter

• Record Nr.: UNINA9910698867603321
• Pubbl/distr/stampa: Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2008]
• Descrizione fisica: i, 3 pages : digital, PDF file
• Soggetti: Pharmacopoeias - Standards - International cooperation; Ash (Combustion product)
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Title from title screen (viewed on May 12, 2009).; "February 2008."
• Nota di bibliografia: Includes bibliographical references (page 3).

Guidance for industry [[electronic resource] ] : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors

• Record Nr.: UNINA9910698867703321
• Pubbl/distr/stampa: Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2006]
• Descrizione fisica: i, 13 pages : digital, PDF file
• Soggetti: Gene therapy - United States - Testing; Retroviruses - United States; Clinical trials - United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Title from PDF title page (viewed on May, 12, 2009).; "November 2006."
• Nota di bibliografia: Includes bibliographical references (pages 10-11).