Detection of Toxicity to Reproduction for Medicinal Products including Toxicity to Male Fertility *)
ثبت نشده
چکیده
Guideline Title Detection of Toxicity to Reproduction for Medicinal Products Including Toxicity to Male Fertility *) Legislative basis Directive 75/318/EEC as amended Date of first adoption First adopted October 1983 This version incorporates version adopted September 1993 and addendum on male fertility adopted 1995. Date of entry into force June 1996 Status Last revised 1995 (male fertility) Previous titles/other references First published in 1983 as Reproduction Studies. Revised version known as ICH S5A: Reproductive Toxicology: Detection of Toxicity to Reproduction for Medicinal Products / III/3387/93, CPMP/ICH/386/95 and ICH S5B: Reproductive Toxicology: Toxicity to Male Fertility / CPMP/ICH/136/95 Additional Notes This note for guidance concerns the application of Part 3, section II. parts B and C of the Annex to Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product. It consolidates a strategy based on study designs currently in use for the testing of medicinal products for toxicity to reproduction. It incorporates the 1995 addendum on male fertility studies (see above).
منابع مشابه
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(r2)
متن کامل
P-38: Protective Effects of Dorema Aucheri (Bilhar) Against Lead Acetate-Induced Reproductive Toxicity in Male Rats
most serious problem that leads to reproductive system failure in both human and animals. Present study was carried out to investigate whether hydroalcholic extract of Dorema aucheri leaves could protect the male rats against lead-induced reproductive toxicity. Materials and Methods: Adult wistar rats were treated with 0.1% lead acetate in drinking water with or without 100, 200 and 400 mg/kg D...
متن کاملP-17: Effects of Garlic (Allium Sativum L), Vitamin E and Cystein on LH and Testosterone Hormone Level Related with Lead Toxicity in The Male Rat
Background: Lead (Pb) is one of the ubiquitous nonessential haevy metals in the environment. There are evidences, which show that lead toxicity has many undesired effects, including neurological, behavioral, immunological, renal, hepatic, male reproductive, dysfunctions. The objective of the present study was to investigate the effects of aqueous garlic extracts, vitamin E and N-Acetylcysteine ...
متن کاملP-43: Reproductive Toxicity of Low Metal Exposureon Male
Background: Recent evidence has indicated a deterioration in reproductive health of men in many countries over the past few decades, particularly a decrease in semen quality and an increase in prevalence of prostate cancer. The human male has a relatively low fertility potential as compared to other mammals. Thus, the human male may be at greater risk from reproductive toxicants. For example, t...
متن کاملZataria multiflora Essential oil Prevent Iron Oxide Nanoparticles-induced Liver Toxicity in Rat Model
Over loading of iron oxide nanoparticles can causes the liver injury through overproduction of free radicals. Zataria multiflora Boiss. (Lamiaceae) has been used for many years in folk medicine due to its antioxidant and antibacterial activities. This study evaluates -for the first time- the effect of Z. multiflora essential oil (EO) against iron oxide nanoparticles hepatotoxicity in rat model....
متن کامل