ABSTRACT
The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for which no New Drug Applications (NDAs) currently exist. However, commercially available generic products for both of these drugs have not been determined by the FDA to be therapeutically equivalent to the innovator products. Generic versions of warfarin have been approved by the FDA as being therapeutically equivalent to the innovator products, as have generic versions of the rescue inhaler albuterol. Yet, misinformation and myths persist regarding the adequacy and proven reliability of the FDA's determination of bioequivalence for these products.
Subject(s)
Drug Approval/methods , Drugs, Generic/standards , Therapeutic Equivalency , United States Food and Drug Administration , Albuterol/pharmacokinetics , Albuterol/standards , Albuterol/supply & distribution , Anticoagulants/pharmacokinetics , Anticoagulants/standards , Anticoagulants/supply & distribution , Bronchodilator Agents/pharmacokinetics , Bronchodilator Agents/standards , Bronchodilator Agents/supply & distribution , Cardiotonic Agents/pharmacokinetics , Cardiotonic Agents/standards , Cardiotonic Agents/supply & distribution , Digoxin/pharmacokinetics , Digoxin/standards , Digoxin/supply & distribution , Drugs, Generic/pharmacokinetics , Drugs, Generic/supply & distribution , Humans , Reproducibility of Results , Thyroxine/pharmacokinetics , Thyroxine/standards , Thyroxine/supply & distribution , United States , Warfarin/pharmacokinetics , Warfarin/standards , Warfarin/supply & distributionABSTRACT
Disorders that cause congenital scoliosis include Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome. We present the case of a 46-year-old karyotypical (XX) woman with müllerian agenesis (MRKH type A, typical form), a rudimentary bicornate uterus, a blind vaginal pouch, and adenocarcinoma of both ovaries with subsequent bilateral salpingo-oophorectomy. She also had scoliosis of the thoracic and lumbar spine, an association thus far seen only among patients with type B (atypical) MRKH. We describe typical and atypical forms of MRKH and emphasize how these various anomalies associated with müllerian agenesis have affected the classification of the syndrome. We also outline possible embryologic etiologies of müllerian agenesis.
Subject(s)
Adenocarcinoma/complications , Mixed Tumor, Mullerian/complications , Ovarian Neoplasms/complications , Scoliosis/etiology , Abnormalities, Multiple , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Female , Humans , Karyotyping , Middle Aged , Mixed Tumor, Mullerian/genetics , Ovarian Neoplasms/pathology , Ovarian Neoplasms/surgery , OvariectomyABSTRACT
Most cases of Morgagni hernia are asymptomatic and diagnosed incidentally on routine chest x-ray film, but they may occasionally become symptomatic. Symptomatic Morgagni hernias may present in many different ways, making the diagnosis challenging. We describe a patient with a Morgagni hernia, resulting in intractable nausea and vomiting, give a brief review of symptoms, note the different types of abdominal contents herniated, and describe the methods used to make the diagnosis.
