A History of Biopharmaceutics in the Food and Drug Administration 1968–1993

Skelly, Jerome P.

doi:10.1208/s12248-009-9154-8

Cited by 24 publications

(11 citation statements)

References 31 publications

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“…The historical aspects of the evolution of bioavailability and BE concepts in the FDA have been reviewed recently 164,165. The landmark of these advances in regulatory science is the introduction of the term “bioavailability' used to describe the extent and rate of drug entrance in the systemic circulation 17,166–168.…”

Section: Regulatory Aspects Of Oral Drug Absorptionmentioning

confidence: 99%

Antituberculosis Therapy–Induced Acute Liver Failure: Magnitude, Profile, Prognosis, and Predictors of Outcome

et al. 2010

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Antituberculosis therapy (ATT)–associated acute liver failure (ATT-ALF) is the commonest drug-induced ALF in South Asia. Prospective studies on ATT-ALF are lacking. The current study prospectively evaluated the magnitude, clinical course, outcome, and prognostic factors in ATT-ALF. From January 1986 to January 2009, 1223 consecutive ALF patients were evaluated: ATT alone was the cause in 70 (5.7%) patients. Another 15 (1.2%) had ATT and simultaneous hepatitis virus infection. In 44 (62.8%) patients, ATT was prescribed empirically without definitive evidence of tuberculosis. ATT-ALF patients were younger (32.87 [±15.8] years), and 49 (70%) of them were women. Most had hyperacute presentation; the median icterus encephalopathy interval was 4.5 (0-30) days. The median duration of ATT before ALF was 30 (7-350) days. At presentation, advanced encephalopathy and cerebral edema were present in 51 (76%) and 29 (41.4%) patients, respectively. Gastrointestinal bleed, seizures, infection, and acute renal failure were documented in seven (10%), five (7.1%), 26 (37.1%), and seven (10%) patients, respectively. Compared with hepatitis E virus (HEV) and non-A non-E–induced ALF, ATT-ALF patients had nearly similar presentations except for older age and less elevation of liver enzymes. The mortality rate among patients with ATT-ALF was high (67.1%, n = 47), and only 23 (32.9%) patients recovered with medical treatment. In multivariate analysis, three factors independently predicted mortality: serum bilirubin (≥10.8 mg/dL), prothrombin time (PT) prolongation (≥26 seconds), and grade III/IV encephalopathy at presentation. Conclusion: ATT-ALF constituted 5.7% of ALF at our center and had a high mortality rate. Because the mortality rate is so high, determining which factors are predictors is less important. A high proportion of patients had consumed ATT empirically, which could have been prevented. Hepatology 2010

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Section: Regulatory Aspects Of Oral Drug Absorptionmentioning

confidence: 99%

Antituberculosis Therapy–Induced Acute Liver Failure: Magnitude, Profile, Prognosis, and Predictors of Outcome

et al. 2010

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“…Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statically significantly different from those of reference product when administered at the same molar dose. If the bioavailability of two formulations administered in the same molar dose is similar, then they are said to be bioequivalent [1][2][3][4][5][6][7][8][9][10]. Different test methods are available to assess equivalence, including:…”

Section: Introductionmentioning

confidence: 99%

Bioavailability and Bioequivalence Studies

Nagadurga¹

2020

Pharmaceutical Formulation Design - Recent Practices

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In vivo bioavailability studies are performed for new drug to establish essential pharmacokinetic parameters including rate of absorption, extent of absorption, rates of excretion and metabolism and elimination half-life after a single and multiple dose administration. These essential pharmacokinetic parameters are useful in establishing dosage regimens. Bioequivalence used to assess the expected in vivo biological equivalence of two proprietary preparations of drug products. If two drugs are bioequivalent, it means that they are expected to be same for all intents and purposes. In determining bioequivalence between two drugs such as a reference drug or brand and potential to be test drug or marketed generic drug. Pharmacokinetic studies are conducted whereby each of the drugs is administered in a cross over study to healthy volunteer's subjects. Plasma is obtained at regular intervals and assayed for parent drug or metabolite concentration to compare the two drugs. For comparison purpose of two formulations, the plasma concentration data are used to assess key pharmacokinetic parameters. If 90% confidence interval for the ratio of the geometric least square means of peak plasma concentration, area under curve of test and reference drugs are within 80-125%, then bioequivalence will be established.

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“…During the early development of bioequivalence, Skelly (2010) suggested the determination of AUC measurements by physically plotting serum concentration versus time on specially weighted paper, cutting out the respective plots, and weighing each plot separately for comparison. This method, known as the Canadian rule of AE20 %, requires that the mean AUC of the generic drug be within 20 % of the mean AUC of the approved product.…”

Section: Bioequivalence Decision Rulesmentioning

confidence: 99%

Bioequivalence History

Sun

et al. 2014

FDA Bioequivalence Standards

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A History of Biopharmaceutics in the Food and Drug Administration 1968–1993

Cited by 24 publications

References 31 publications

Antituberculosis Therapy–Induced Acute Liver Failure: Magnitude, Profile, Prognosis, and Predictors of Outcome

Antituberculosis Therapy–Induced Acute Liver Failure: Magnitude, Profile, Prognosis, and Predictors of Outcome

Bioavailability and Bioequivalence Studies

Bioequivalence History

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