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BE guidelines regarding investigator

BE guidelines recommend investigator should possess appropriate medical qualification, experience for conducting pharmacokinetic studies Can chairperson of EC directly write to sponsor to clarify some of the queries of clinical trial raised in EC meeting? Dr. Sreevatsa Please see an extract from FDA's comment on IRB-sponsor relationship. The interrelationship and interaction between the research sponsor (e.g., drug, biologic and device manufacturers), the clinical investigator and the Institutional Review Board (IRB) may be very complex. The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study. The clinical investigator generally provides the communication link between the IRB and the sponsor. Such linkage is agreed to by the sponsors and investigators when they sign forms FDA-1571 and FDA-1572, respectively, for drug and biologic studies or a...
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Isotretinoin in India: A tragedy in the offing

Isotretinoin in India: A tragedy in the offing Wednesday, March 28, 2007 08:00 IST  Seema Thakral Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased ris...
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Combination Vaccine for Kids withdrawn

A vaccine that combines conventional MMR (Measles, Mumps, Rubella) with Chikenpox has been withdrawn in the United States due to a higher rate of seizures in children. In a study children aged 12 to 23 months who received the combined MMR cum Chickenpox vaccine had double the rate of seizures compared to children who got separate vaccine for MMR and chickenpox. This equates to one additional case of convulsion per 2000 vaccinations.
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