Pharmaceutical Regulatory Affairs: Drug Development, Approval and Clinical Research For B.Pharm Semester VII | Course Code - Couverture rigide

Dr. Putta Ravi; R. M. Rao Kusumanchi And Vamshi K. Lekkala.

Couverture rigide

ISBN 13 : 9798907224193

Editeur : Notion Press, 2026

Synopsis

Pharmaceutical development is governed not only by scientific discovery, but by the regulatory evidence required to establish quality, safety, efficacy and responsible clinical use. Written for B.Pharm Semester VII students under the PCI 2026 framework, this textbook develops Regulatory Affairs as an applied pharmaceutical discipline linking drug development, regulatory decision-making and protection of public health.The text progresses from regulatory principles, terminology and major authorities to drug discovery, non-clinical evaluation, regulatory documentation and clinical development.

It examines CDSCO and State Licensing Authorities in India, international agencies including the US FDA, EMA and PMDA, IND, NDA and ANDA pathways, Drug Master Files, bioequivalence, generic and phytopharmaceutical regulation, CTD, eCTD and ACTD submissions, overseas registration and post-approval changes. Clinical research phases, IRB and IEC functions, informed consent, Good Clinical Practice, trial monitoring and pharmacovigilance are integrated within the wider product lifecycle.

Clear explanations emphasise why regulatory requirements exist, how evidence is generated and documented, and how regulators use that evidence in review and approval. Jurisdiction-specific concepts are carefully distinguished, while historical provisions are placed in appropriate context.

Détails de l'édition

• Éditeur: Notion Press
• Date d'édition: 2026
• Langue: anglais
• ISBN 13: 9798907224193
• Reliure: Relié
• Nombre de pages: 372
• Coordonnées du fabricant: non disponible
• Personne responsable: gpsr@libri.de; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Allemagne