The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in these formulations.
Highlights from Semisolid Products, Volume Four include:
- coverage of over 350 formulations
- valuable information on the difficult area of compliance
- changes to approved new drug applications and abbreviated new drug applications
- the evolving guidelines of ICH and when to conduct a regulatory review
