Industrial perspective: From IND to NDA

Giering, Linda P.; Smith, James E.

doi:10.1016/s1071-3581(05)80010-8

Cited by 6 publications

(3 citation statements)

References 8 publications

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“…During these phases the investigational new drugs (IND) are tested in humans under ideal and controlled conditions, gathering an exposure experience that, although robust, only comprises several hundreds or at best a few thousands of patients. After completion of phase III randomized clinical trials (RCT) demonstrating both efficacy and safety, approval of new drug application (NDA) is required for the drug to be marketed [Giering and Smith, 1995]. However, this well-rounded system of drug development is not without flaws, and during the postmarketing era, some issues may bring uncertainty to the by then established data.…”

Section: The Drug Approval Process and Postmarketing Surveillancementioning

confidence: 99%

Review: Efficacy and safety of tenofovir disoproxil fumarate in patients with chronic hepatitis B

Duarte‐Rojo

Heathcote

2010

Therap Adv Gastroenterol

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Chronic hepatitis B (CHB) is prevalent worldwide. It may cause cirrhosis and hepatocellular carcinoma. Treatment for this condition may need to be lifelong, thus the drugs used must be both efficacious and safe. Clinical trials of tenofovir have demonstrated a good safety profile for this drug and it has potent antiviral properties. However, to better characterize the safety of this drug, the postmarketing surveillance must be taken into account. Clinicians need to be vigilant, as infrequent adverse events may be revealed during this phase. The current review presents a detailed exposé of preclinical and clinical data on tenofovir to increase awareness of possible adverse events and drug-drug interactions, based on the large experience of this drug in human immunodeficiency virus (HIV) treatment (and to date in patients with CHB). Several recommendations that may help the clinician to prevent the development of adverse events associated with tenofovir disoproxil fumarate (TDF) treatment are outlined, along with a suggested surveillance protocol for the timely and proper identification of possible renal and bone toxicity.

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Section: The Drug Approval Process and Postmarketing Surveillancementioning

confidence: 99%

Review: Efficacy and safety of tenofovir disoproxil fumarate in patients with chronic hepatitis B

Duarte‐Rojo

Heathcote

2010

Therap Adv Gastroenterol

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“…9 Numbers of MPS studies in selected countries in 1994 (except where stated). (Adapted from references [ 280 ] and [ 290 ]) …”

Section: Service Provisionmentioning

confidence: 99%

Myocardial perfusion scintigraphy: the evidence

Underwood

Anagnostopoulos

Cerqueira

et al. 2003

Eur J Nucl Med Mol Imaging

421

199

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“…Thus, although we were performing only a quarter of European activity in 1994, we may have started to catch up. Comparisons with Europe and the USA,12 show the UK at the lower end of activity for MPI among countries of similar economic status (fig 1). This situation is exacerbated by our high standardised mortality rates for coronary artery disease, which suggest that our rate for cardiovascular investigations should be higher than other countries.…”

Section: The Futurementioning

confidence: 95%

Nuclear cardiology in the UK 1994: activity relative to Europe, USA, and British Cardiac Society targets

Pennell

Prvulovich

Tweddel

et al. 1998

Heart

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Objective-To survey practice in nuclear cardiology in the UK in 1994. Design-A questionnaire was sent to 219 centres performing nuclear imaging asking for details of current practice in nuclear cardiology. Replies were received from 192 centres (88%). Main outcome measures-Activity in performance of myocardial perfusion imaging (MPI) and radionuclide ventriculography (RNV), anticipated changes in activity, diVerences between regional and district hospitals, technical imaging parameters, and referral sources. Results-Of the responding centres, 125 (65%) performed nuclear cardiology procedures. More regional than district hospitals performed nuclear cardiology procedures (85% v 55%, p < 0.0003) and regional centres performed a higher proportion (62% v 24%, p < 0.001) of nuclear cardiology activity. Nuclear cardiology activity was 0.82 scans per 1000 population per year (MPI 0.56, RNV 0.26). There has been a significant increase (24%) in nuclear cardiology since 1988. There has been a pronounced rise in MPI (350%) while RNV has fallen by 47%. Myocardial perfusion activity in the UK remains very low (25% and 5% in regional and district hospitals, respectively) compared with the 1994 figures of 2.2/1000/year for Europe or 10.8/1000/year for the USA. Conclusions-MPI has increased on average by 23%/annum (compound rate) since 1988, but in 1994 was still only 32% of the British Cardiac Society target of 2.6/1000/ year. Proper resources for capital expenditure on new equipment and new staff will be important to maintain momentum in closing the gap. Also important is improved clinical understanding, as already implemented by including nuclear cardiology in guidelines for specialist cardiology training. (Heart 1998;80:296-298)

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Industrial perspective: From IND to NDA

Cited by 6 publications

References 8 publications

Review: Efficacy and safety of tenofovir disoproxil fumarate in patients with chronic hepatitis B

Review: Efficacy and safety of tenofovir disoproxil fumarate in patients with chronic hepatitis B

Myocardial perfusion scintigraphy: the evidence

Nuclear cardiology in the UK 1994: activity relative to Europe, USA, and British Cardiac Society targets

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