Real-life Bioequivalence of Tacrolimus in Patients With Living-Related Donor De Novo Renal Transplantation: An Observational Study

Naithani, Priyanka; Dey, Sumit; Attri, Savita Verma; Patil, Amol; Patial, Ajay; Singh, Sheetal; Panwar, Ritika; Sivakumar, Suganya; Singh, Sarbpreet; Kenwar, Deepesh Benjamin; Pattanaik, Smita; Sharma, Ashish

doi:10.1016/j.transproceed.2020.03.017

Cited by 1 publication

(2 citation statements)

References 7 publications

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“…Moreover, when a generic replacement is done for a drug that traditionally requires TDM for dose optimisation or monitoring of therapy (e.g., AED, ATD, antibiotics, antipsychotics), the availability of TDM service is undoubtedly desirable. This is of particular concern for drugs with a narrow therapeutic index such as tacrolimus, where a generic product can lead to serious fluctuations in drug concentration, resulting in adverse outcomes such as transplant rejection or nephrotoxicity 99 . These issues still need to be addressed, but wider availability and application of TDM would circumvent such problems and facilitate seamless generic substitution, increasing physicians' confidence.…”

Section: Strengthsmentioning

confidence: 99%

“…This is of particular concern for drugs with a narrow therapeutic index such as tacrolimus, where a generic product can lead to serious fluctuations in drug concentration, resulting in adverse outcomes such as transplant rejection or nephrotoxicity. 99 These issues still need to be addressed, but wider availability and application of TDM would circumvent such problems and facilitate seamless generic substitution, increasing physicians' confidence.…”

Section: Availability Of Genericsmentioning

confidence: 99%

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Therapeutic drug monitoring in India: A strength, weakness, opportunity and threats analysis

Pattanaik

Gota

Tripathi

et al. 2023

Brit J Clinical Pharma

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Over the last three to four decades, Therapeutic Drug Monitoring (TDM) has shaped itself as therapeutic drug management, an integral component of precision medicine. The practice of TDM is not extensive in India, despite being one of the fastest‐growing economies in the world. It is currently limited to a few academic medical centres and teaching hospitals. Apart from the immunosuppressive drugs, several other therapeutic areas, such as anticancer, antifungal, antibiotic and antitubercular, have demonstrated great potential to improve patient outcomes in Indian settings. Factors such as the higher prevalence of nutritional deficiencies, tropical diseases, widespread use of alternative medicines, unalike pharmacogenomics and sparse population‐specific data available on therapeutic ranges of several drugs make the population of this subcontinent unique regarding the relevance of TDM. Despite the impact of TDM in clinical science and its widespread application, TDM has failed to receive the attention it deserves in India. This review intends to bring out a strength, weakness, opportunity and threats (SWOT) analysis for TDM in India so that appropriate steps for fostering the growth of TDM could be envisioned. The need of the hour is the creation of a cooperative group including all the stakeholders, such as TDM professionals, clinicians and the government and devising a National Action Plan to strengthen TDM. Nodal TDM centres should be established, and pilot programmes should be rolled out to identify the thrust areas for TDM in the country, capacity building and creating awareness to integrate TDM into mainstream clinical medicine.

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Section: Strengthsmentioning

confidence: 99%

Section: Availability Of Genericsmentioning

confidence: 99%