Download e-book for iPad: Nonclinical Safety Assessment: A Guide to International by William J. Brock,Kenneth L. Hastings,Kathy M. McGown

By William J. Brock,Kenneth L. Hastings,Kathy M. McGown

Bringing a brand new drug to marketplace is a expensive time-consuming technique. elevated local and foreign law over the past 20 years, whereas valuable, has basically served to enlarge those charges. in accordance with this escalation, developmental options have shifted in the direction of a extra worldwide technique. for you to create the main least expensive and secure techniques, it's serious for these bringing medicinal drugs to marketplace to appreciate either the globally accredited laws and the neighborhood diversifications. Nonclinical safeguard overview: A advisor to overseas Pharmaceutical Regulations presents a realistic description of nonclinical drug improvement laws and necessities within the significant marketplace areas.

It includes:

  • ICH – the overseas convention on Harmonisation of Technical necessities for Registration of prescription drugs for Human Use
  • National rules, together with US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia
  • Repeated dose toxicity studies
  • Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology
  • Biotechnology-derived pharmaceuticals
  • Vaccine development
  • Phototoxicity and photocarcinogenicity
  • Degradants, impurities, excipients and metabolites

Primarily meant for these pros actively keen on the nonclinical and scientific improvement of a pharmaceutical product, together with toxicologists, pharmacologists, clinicians and venture managers, this publication offers a roadmap for winning new drug approval and marketing.

Show description

Read Online or Download Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations PDF

Best pharmacology books

New PDF release: Drug-Drug Interactions: Scientific and Regulatory

Drug–Drug Interactions is a finished assessment of the clinical and regulatory views of drug–drug interactions from the point-of-view of academia, undefined, and govt regulatory enterprises. This publication is meant for execs within the pharmaceutical undefined, future health care, and governmental regulatory firms.

New PDF release: Transdermal Drug Delivery Systems: Revised and Expanded

Provides authoritative state of the art discussions of the major concerns pertinent to transdermal drug supply, reading these issues essential to allow a severe review of a drug candidate's capability to be added around the epidermis; from actual chemistry and evaluation of drug permeability to to be had enhancement technolgies, to regulatory approval.

Download PDF by Committee to Review California's Risk-Assessment Process for: Review of California's Risk-Assessment Process for

The California division of Pesticide Regulation(DPR)conducts human wellbeing and fitness possibility exams as a part of its project to make sure the security of employees and public future health within the nation. the chance exams establish power health and wellbeing risks posed via insecticides, symbolize dose-response relationships, and estimate publicity to signify capability dangers to people.

Download e-book for iPad: Pharmamarketing: Ein Leitfaden für die tägliche Praxis by Trilling

Dieser Praxisleitfaden ist für den täglichen Einsatz konzipiert - als täglicher Assistent des Produktmanagers, der erfolgreich im advertising and marketing in der Pharmaindustrie arbeiten will. Das Buch liefert einen Überblick über alle wichtigen Aspekte des Pharmamarketing, weist auf mögliche Fallstricke hin und gibt praktische Hilfestellungen für die Planung und Durchführung der verschiedenen Marketingprojekte.

Extra resources for Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations

Example text

Download PDF sample

Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations by William J. Brock,Kenneth L. Hastings,Kathy M. McGown


by Kenneth
4.4

Rated 4.12 of 5 – based on 32 votes