Bioequivalence and other unresolved issues in generic drug substitution

Meredith, Peter A.

doi:10.1016/s0149-2918(03)80340-5

Cited by 182 publications

(174 citation statements)

References 32 publications

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“…The majority [96% (95% CI 91-98)] of participating patients confirmed that they had undergone a kidney transplant more than a year ago. In addition, more than two-thirds were taking more than seven medications [44% (95% CI 36-52) were taking between 7 and 9 medications and 27% (95% CI [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] were taking more than nine medications]. In addition, 74/147 participants [50.34% (95% CI 42-59)] were highly educated (graduated from college, university or postgraduate) and 73/147 participants [49.66% (95% CI 41-58)] were less educated (graduated from secondary school, vocational training or sixth forms) ( Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…Although there are few published articles to evaluate patients' views on drug substitution, some have shown that drug substitution can be problematic [14,23]. For example, a survey of patients in the UK has shown that over 20% reported that they would be very or extremely concerned if their prescription was changed, even with their doctor's approval.…”

Section: Discussionmentioning

confidence: 99%

“…Small differences in some particular medicines during manufacturing could theoretically result in a risk of significant adverse effects or loss of efficacy [14][15][16]. Many other studies indicated that patients need to be informed adequately about the equivalence of the branded and the generic medicines otherwise, generic substitution will be challenging [14,23,27,30].…”

Section: Discussionmentioning

confidence: 99%

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A survey to determine the views of renal transplant patients on generic substitution in the UK

Ameri

Whittaker

Tucker

et al. 2011

Transplant International

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Summary Rising healthcare costs promote the generic substitution among patients because it is identifiable costs. A key concern is that patients should be involved in the decision of switching. The aim of this study was to examine renal transplant patients’ views on generic substitution in the UK. A total of 163 renal patients were surveyed using 36 multiple‐choice questions at Barts and The London Renal Transplant Clinic, in the UK. Transplant recipients over 18 years, able to read and write English and willing to fill in the questionnaire were targeted; 84% of patients were conscious of the availability of generic medicines, 70% understood the terms “generic” and “branded” in relation to medicines and 54% were aware of generic substitution practice. However, 75% did not know if they were taking generics and 84% felt that generics are not equivalent or only equivalent sometimes and they were uncertain that generics had the same quality as branded medicines. Moreover, many patients admitted that they would not accept the generic substitution of ciclosporin when become available in the UK. A number of factors such as patients’ education, knowledge, severity of the disease, efficacy of generic medicines and patients’ involvement in decisions regarding their health appear to drive patients’ attitudes towards generic substitution.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A survey to determine the views of renal transplant patients on generic substitution in the UK

Ameri

Whittaker

Tucker

et al. 2011

Transplant International

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“…This percentage rose to 20% in 1984, and 40% in 1991. Indeed substitution of generic drugs for brand name products is highly controversial and is often met with suspicion by health care providers and patients (Covington, 1992;Meredith, 2003). The FDA has mandated that all generic drugs meet the same standards as the brand name drugs in strength, safety, purity and performance.…”

Section: Introductionmentioning

confidence: 99%

Quality Assessment of the Commonly Prescribed Antimicrobial Drug, Ciprofloxacin Tablets, Marketed in Tigray, Ethiopia

Kahsay¹,

Egziabher²

2010

mejs

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An attempt was made to assess the quality and compare the physicochemical equivalence of six brands of ciprofloxacin tablets marketed in Tigray, Ethiopia. Six brands of ciprofloxacin tablets were used in the study. Identity, weight uniformity test, disintegration test, dissolution test and assay for the content of active ingredients were performed using the methods described in the British Pharmacopoeia. All the samples passed the identity, disintegration, and dissolution tests but Ciflox failed to release 80% of the drug content within 30 minutes as stipulated in the pharmacopoeia. This product therefore does not comply with the BP 2004 dissolution tolerance limits. All of the brands examined pass the assay for content of active ingredient. This work revealed that the six brands included in the study complied with the physicochemical quality parameters except Ciflox which failed to meet the pharmacopoeial specification for dissolution test. Nevertheless the six brands showed that there is significant difference in the drug release in vitro (p<0.05). To justify the specification limits of the in vitro dissolution test, an attempt should be made to establish a meaningful correlation between in vitro release characteristics and in vivo bioavailability parameters.

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“…The perception of physicians, the consumers or the health care providers towards the generics play a major role in their acceptance. There have been number of cases, where the acceptance of generics has become questionable by the consumers (Meredith, 2003). This perception becomes more fixed as the severity of medical condition of the patient increases.…”

Section: Introductionmentioning

confidence: 99%

Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

Kaushal¹,

Singh²,

Gulati³

et al. 2016

J App Pharm Sci

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In the last one decade, due to expiry of patented products as well as their exclusivity period, a drastic decline of branded pharmaceutical products and up streaming of generic drug market has been observed in developed as well as developing nations. This up rise in generic drug market is expected to rise in future till the arrival of new brand in market. This prevailing conditions could result in proliferation of generic drug manufacturing companies. The fact that generics do not undergo thorough extensive trials like innovator drugs, fuels further fears regarding their inferiority. Moreover, due to the hard competition amongst various companies to market their generics, the frequency of fraud and corruption have embarked doubts in consumers mind to reality. In order to blow away the doubts and re-establishing the credibility of generics in market, bioequivalence (BE) guidelines with stricter regulation should be the demand. The present study highlights the relevant regulatory guidelines for the conduct of bioequivalence studies in US, Europe, Canada, India, South Africa and South East Asian Nations. A comparative study of the differences in study design and specifications have also been addressed.

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Bioequivalence and other unresolved issues in generic drug substitution

Cited by 182 publications

References 32 publications

A survey to determine the views of renal transplant patients on generic substitution in the UK

A survey to determine the views of renal transplant patients on generic substitution in the UK

Quality Assessment of the Commonly Prescribed Antimicrobial Drug, Ciprofloxacin Tablets, Marketed in Tigray, Ethiopia

Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

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