ISSN

0974-4150 (Online)
0974-4169 (Print)


Author(s): D. Mamatha, Hindustan Abdul Ahad, G. Ushasree, K. Vinod, C. Haranath, P. Kiran

Email(s): abdulhindustan@gmail.com

DOI: 10.52711/0974-4150.2023.00069   

Address: D. Mamatha1*, Hindustan Abdul Ahad2, G. Ushasree3, K. Vinod3, C. Haranath2, P. Kiran4
1Department of Pharmaceutical Quality Assurance, Raghavendra Institute of Pharmaceutical Education and Research (RIPER) - Autonomous, Ananthapuramu - 515721, Andhra Pradesh, India.
2Department of Pharmaceutics, RR College of Pharmacy, Chikkabanavara, Bengaluru - 90, Karnataka, India.
3Department of Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research (RIPER) - Autonomous, Ananthapuramu - 515721, Andhra Pradesh, India.
4Department of Pharmacology, Raghavendra Institute of Pharmaceutical Education and Research (RIPER)-Autonomous, Ananthapuramu - 515721, Andhra Pradesh, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 6,     Year - 2023


ABSTRACT:
The primary goal of the evaluation is to ensure the product's quality by locating and managing "out of trend" (OOT) areas, utilising various techniques in the pharmaceutical sector. Regression control charts, time points, and slope control charts can all be used to identify or detect OOT. At the time of handling, OOT is divided into three categories: analytical alert, process control alert, and compliance alert. The electrical OOT Tracking Software from Ample Logic, created using low-code technology, is used to manage OOT. Identification of OOT stability results is an increasingly important topic in the pharmaceutical industry. In a perfect world, finding or detecting an OOT would be easy. However, an oversimplified system might not be sensitive enough to detect a genuine OOT. It should be chosen based on how the approach would impact the parameter being evaluated. This article outlines several tactics, such as how to recognise an unexpected single result or unusual variance. When numerous tests and time points call for OOT constraints, OOT detection can be a difficult problem. Additionally, it includes components and software that help manage OOT discoveries.


Cite this article:
D. Mamatha, Hindustan Abdul Ahad, G. Ushasree, K. Vinod, C. Haranath, P. Kiran. Out-of-Trend Statistics in The Pharmaceutical Industry: A Gain Leap in Assuring the Quality of The product. Asian Journal of Research in Chemistry. 2023; 16(6):423-8. doi: 10.52711/0974-4150.2023.00069

Cite(Electronic):
D. Mamatha, Hindustan Abdul Ahad, G. Ushasree, K. Vinod, C. Haranath, P. Kiran. Out-of-Trend Statistics in The Pharmaceutical Industry: A Gain Leap in Assuring the Quality of The product. Asian Journal of Research in Chemistry. 2023; 16(6):423-8. doi: 10.52711/0974-4150.2023.00069   Available on: https://ajrconline.org/AbstractView.aspx?PID=2023-16-6-5


REFERENCES:
1.    Mihalovits M, Kemény S. Regression control chart with unknown parameters for detection of out-of-trend results in pharmaceutical on-going stability studies. Journal of Pharmaceutical and Biomedical Analysis. 2020; 188:113375.
2.    Szél E, Bozó R, Hunyadi-Gulyás É, Manczinger M, Szabó K, Kemény L, Bata-Csörgő Z, Groma G. Comprehensive proteomic analysis reveals the intermediate stage of non-lesional psoriatic skin and points out the importance of proteins outside this trend. Scientific Reports. 2019; 9(1):1-5.
3.    Mohammed Imtiaz Ahmed. Web Content Management in Library Science: An Information Technology Perspective. Asian J. Management. 2010; 1(2): 84-89.
4.    Mehvish Anjum. Strengthening Financial Position through Profit Maximisation a Study on Controllable Factors via Indian Wrist Watch Industry. Asian J. Management. 2011; 2(2): 77-80.
5.    Alhakeem MA, Ghica MV, Pîrvu CD, Anuța V, Popa L. Analytical quality by design with the lifecycle approach: A modern epitome for analytical method development. Acta Marisiensis-Seria Medica. 2019; 65(2): 37-44.
6.    Ahad HA, Haranath C, Rahul Raghav D, Gowthami M, Naga Jyothi V, Sravanthi P. Overview on recent optimization techniques in gastro retentive microcapsules by factorial design. Int J Pharm Sci Res. 2019; 10(9): 247-54.
7.    Chinthaginjala H, Ahad HA, Bhargav E, Pradeepkumar B. Central Composite Design Aided Formulation Development and Optimization of Clarythromycin Extended-Release Tablets. Indian Journal of Pharmaceutical Education and Research. 2021; 55(2): 395-406.
8.    Bianchi M, Cavaliere A, Chiaroni D, Frattini F, Chiesa V. Organisational modes for Open Innovation in the bio-pharmaceutical industry: An exploratory analysis. Technovation. 2011; 31(1): 22-33.
9.    Schuhmacher A, Germann PG, Trill H, Gassmann O. Models for open innovation in the pharmaceutical industry. Drug Discovery Today. 2013; 18(23-24): 1133-7.
10.    Jaiswal H, Muddukrishna BS, Kulyadi GP. Data integrity violations: A challenge to the pharmaceutical industry. Quality Assurance. 2020; 5: 16.
11.    Chinthaginjala H, Ahad HA, Samhitharao B, Yasaswini VS, Madana G, Varam NJ, Dasari R. Formulation and In Vitro Evaluation of Fast Disintegrating Tablets of an Anti-Inflammatory Drug using Natural Super Disintegrating Agents. Int. J. Life Sci. Pharma Res. 2021; 2: 9-18.
12.    Chaitanya MV, Chinni S, Jyothia MV, Reddy YP. The Importance of Quality Management System for a Successful Health Care Industry: A Review Based on Case Studies. Journal of Chemical and Pharmaceutical Research. 2018; 10(8): 143-9.
13.    Shravani Y, Ahad HA, Haranath C, gari Poojitha B, Rahamathulla S, Rupasree A. Past Decade Work Done on Cubosomes Using Factorial Design: A Fast Track Information for Researchers. Int. J. Life Sci. Pharma Res. 2021; 11(1): 124-135.
14.    Flanders W. Opting out: Enrollment trends in response to continued public school shutdowns. Journal of School Choice. 2021; 15(3): 331-43.
15.    S. Muneer, Hindustan Abdul Ahad, Chandra Sekhar Kothapalli Bonnoth. A Novel Stability Indicating RP-HPLC Assay Method Development and Validation for the Quantification of Cyamemazine Tartrate in bulk and its Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2018; 8(3): 169-173.
16.    Yu B, Zeng L, Ren P, Yang H. A unified framework for detecting out-of-trend results in stability studies. Statistics in Biopharmaceutical Research. 2018; 10(4):237-43.
17.    Hindustan AA, Babu UA, Nagesh K, Kiran DS, Madhavi KB. Fabrication of glimepiride Datura stramonium leaves mucilage and poly vinyl pyrrolidone sustained release matrix tablets: in vitro evaluation. Kathmandu University Journal of Science, Engineering and Technology. 2012; 8(1): 63-72.
18.    Hindustan Abdul Ahad, Chinthaginjala Haranath, Bhupalam Pradeep Kumar, Debaraj Roy, Bhavani Haribabu Sai Dharani, Momin Umaira Ayisha. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(3): 247-2.
19.    Wande DP, Sangeda RZ, Tibalinda P, Mutta IK, Mkumbwa S, Bitegeko A, Kaale E. Pharmaceuticals imports in Tanzania: an overview of private sector market size, share, growth and projected trends to 2021. PloS one. 2019; 14(8): e0220701.
20.    Yadiki MN, Suggala VS, Puchalapalli DS, Ahad HA. Temperature and Exposure Time Impact on the Extraction of Opuntiaficus-indica and Opuntia dillenii Cladodes on% Yield as a Response: Screening using Design Expert Software. Global Journal of Medical, Pharmaceutical, and Biomedical Update. 2022; 17.
21.    Darmawan LV, Hutajulu M, Sianturi JV, Muda I. Fairness, Disclosures and Future Trends in Accounting for Pharmaceutical Companies. Journal of Pharmaceutical Negative Results. 2022: 1638-44.
22.    Bandagisa Fouziya, Hindustan Abdul Ahad, Dontha Swamy Charan, Jagarlamudi Sri Vidya, Ummadi Chandana Reddy, Puli Nandini Reddy. Fabrication and Evaluation of Cefpodoxime Proxetil Niosomes. Asian Journal of Pharmacy and Technology. 2022; 12(2):109-2.
23.    Hindustan Abdul Ahad, Haranath Chinthaginjala, Gangireddy Jayasimha Reddy, Pasupuleti Dheeraj Krishna, Syed Rahamathulla, Jyothi Vinay Krishna. Abbreviated New Drug Application Process: A Gift for The Industry and The Patients. Asian Journal of Research in Chemistry. 2021; 14(5):331-5.
24.    Chinthaginjala H, Barghav GC, Reddy CM, Pradeepkumar B, Ahad HA, Akbari BV, Dholakiya RB, Shiyani BG, Lodhiya DJ, Shastry CS. Formulation and in vitro evaluation of floating tablets of dicloxacillin sodium using different polymers. Journal of Young Pharmacists. 2019; 11(3): 247.
25.    Sahani P, Srilatha KS, Ahad HA, Sah SK, Dkhar B, Prajapati RK. From Concept to Assessment: Creating an Oral In-Situ Gelling System with Sucralfate. KEPES. 2023; 21(3): 555-67.
26.    Uddin M. Blockchain Medledger: Hyperledger fabric enabled drug traceability system for counterfeit drugs in pharmaceutical industry. International Journal of Pharmaceutics. 2021; 597: 120235.
27.    Suresh K, Hindustan AA, Satyanarayana SV. Antioxidant activity and Hepatoprotective potential of Ethanolic leaf extract of Artabotryshexapetalus against various Hepatotoxins induced Hepatotoxicity in Albino wister Rats. Int. J. Res. Pharm. Sci. 2021; 12: 1679-88.
28.    Hindustan Abdul Ahad, Haranath Chintaginjala, Syed Rahamathulla, AswarthanarayanaRupasree, Anegondithimmappa Sajan Kumar, Barji Prasanna Pallavi. Pathfinder Nanosponges for Drug Targeting by Factorial Design: A Glance Review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(4):341-4.
29.    Kousar S, Ahad HA, Chinthaginjala H, Babafakruddin P, Lakunde J, Tarun K. Gas Generating Floating Tablets: A Quick Literature Review for the Scholars. Asian Journal of Research in Chemistry. 2022 ;15(2): 171-5.
30.    Abualhaija S, Arora C, Sabetzadeh M, Briand LC, Vaz E. A machine learning-based approach for demarcating requirements in textual specifications. In2019 IEEE 27th International Requirements Engineering Conference (RE) 2019 Sep 23 (pp. 51-62). IEEE.
31.    Babu GN, Muthukaruppan M, Ahad HA. Impact of Azadirachtaindica Fruit Mucilage on particle size and swelling index in Central Composite Designed Acyclovir mucoadhesive microspheres. Baghdad Science Journal. 2023;20(2): 425.
32.    Kappala Sailaja, Hindustan Abdul Ahad, Haranath Chinthaginjala, Renuka Gudisipalli, SugaliIndravath Rajyalakshmi, Yamuna Vagganagari. Research Journal of Pharmaceutical Dosage Forms and Technology. 2022; 14(3): 245-8.
33.    Garcia-Muiña FE, González-Sánchez R, Ferrari AM, Volpi L, Pini M, Siligardi C, Settembre-Blundo D. Identifying the equilibrium point between sustainability goals and circular economy practices in an Industry 4.0 manufacturing context using eco-design. Social Sciences. 2019; 8(8): 241.
34.    Molodtsova T, Papell DH. Out-of-sample exchange rate predictability with Taylor rule fundamentals. Journal of International Economics. 2009; 77(2): 167-80.
35.    Sandell D, Tougas T. Quality considerations in the establishment of specifications for pharmaceuticals. Statistics in Biopharmaceutical Research. 2012; 4(2): 125-35.
36.    Wu J, Song X, Xiao Z. Testing for Trend Specifications in Panel Data Models. Journal of Business & Economic Statistics. 2022:1-4.
37.    Hindustan Abdul Ahad, Haranath Chinthaginjala, Nagarajugari Kavyasree, Jyothi Vinay Krishna, Sushma Papireddypalli, Kotlo Saijyoshna. A Recent attempt made on Fast Disintegrating Tablets: A Precise Review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2022; 14(3):229-2.
38.    Industan Abdul Ahad, Haranath Chinthaginjala, Nagarajugari Kavyasree, Jyothi Vinay Krishna, Sushma Papireddypalli, Kotlo Saijyoshna. A Recent attempt made on Fast Disintegrating Tablets: A Precise Review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2022; 14(3): 229-2.
39.    Shobhit Bajpayee, Swati Tiwari. Recent Trend of Retail Business in Chhattisgarh: With special reference to Bilaspur, Chhattisgarh. Asian J. Management. 2014; 5(2): 261-264.
40.    Luci-Greulich A, Thévenon O. The Impact of Family Policies on Fertility Trends in Developed Countries: L’influence des politiques familiales sur les tendances de la fécondité des pays développés. European Journal of Population/Revue européenne de Démographie. 2013; 29: 387-416.
41.    Muiambo CC, Joao IM, Navas HV. Lean waste assessment in a laboratory for training chemical analysts for the pharmaceutical industry. International Journal of Lean Six Sigma. 2022; 13(1): 178-202.
42.    Babu GN, Muthukarupan M, Ahad HA, Sreedhar V. Fabrication and Preliminary Assessment of Neem Fruit Mucilage as Mucoadhesive Abetting Assets with Methpol-934P for Acyclovir Delivery from Mucoadhesive Microcapsules. Biomedical and Pharmacology Journal. 2022; 15(4): 2179-84.
43.    Roesti D, Goverde M. Data Integrity and Microbiological Excursion Handling. Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non‐Sterile Manufacturing. 2019: 401-28.
44.    Jain AA, Mane-Kolpe PD, Parekar PB, Todkari AV, Sul KT, Shivpuje SS. Brief review on Total Quality Management in Pharmaceutical Industries. International Journal of Pharmaceutical Research and Applications. 2022; 7(5):1030-6.
45.    Santos RN, Yamouni S, Albiero B, Vicente R, A Silva J, FB Souza T, CM Freitas Souza M, Lei Z. Gradient boosting and Shapley additive explanations for fraud detection in electricity distribution grids. International Transactions on Electrical Energy Systems. 2021; 31(9): e13046.
46.    Neeti Roy, Yogendra Jain. Education through ICT Technology: Need of an hour. Asian J. Management. 2014; 5(2): 246-249.
47.    Patel Dhaval V, Patel Biraju D, Patel Nilesh K, Sheth Navin R, Dabhi Mahesh R, Dudhrejiya Ashvin V. Quality Improvement Methodologies in Pharmaceutical Manufacturing. Asian J. Management. 2010; 1(1): 1-3
48.    Xia Y, He L, Li Y, Fu Y, Xu Y. A dynamic credit scoring model based on survival gradient boosting decision tree approach. Technological and Economic Development of Economy. 2021; 27(1): 96-119.
49.    Stanisic N, Radojevic T, Stanic N. Predicting the type of auditor opinion: Statistics, machine learning, or a combination of the two?. Machine Learning, or a Combination of the Two. 2019: 1-58.
50.    Cadinoska MV, Popstefanova N, Ilievska M, Karadzinska E, Jovanoska MD, Dodov MG. Trending and Out-of-Trend results in pharmaceutical industry. Macedonian Pharmaceutical Bulletin. 2019; 65(1).
51.    Modhave D, Barrios B, Paudel A. PVP-H2O2 complex as a new stressor for the accelerated oxidation study of pharmaceutical solids. Pharmaceutics. 2019; 11(9): 457.
52.    Tome T, Žigart N, Časar Z, Obreza A. Development and optimization of liquid chromatography analytical methods by using AQbD principles: Overview and recent advances. Organic Process Research & Development. 2019; 23(9): 1784-802.



Recomonded Articles:

Author(s): Bhavna V. Mohite

DOI:         Access: Open Access Read More

Author(s): Ravi N. Patel, Urviben Y. Patel, Kiran M. Patel, Jimit S. Patel, Ankit D. Patel, Dhrubo Jyoti Sen

DOI:         Access: Open Access Read More

Author(s): Y. Padmavathi, Akari Anjali, Nayaka Raghavendra Babu, P Ravi Kumar

DOI: 10.5958/0974-4150.2017.00064.5         Access: Open Access Read More

Author(s): Chavan Pooja Ajit, Avinash Mahadeo Bhagwat, Atul Prabhakar Chaudhari

DOI: 10.52711/0974-4150.2021.00061         Access: Open Access Read More

Author(s): Tripti Jain, V Jain, R Pandey, A Vyas, S Gandhi, SS Shukla

DOI:         Access: Open Access Read More

Author(s): Bulusu Lakshmi Sushma1, Gutta Madhusudhan, Anireddy Jayashree

DOI: 10.5958/0974-4150.2017.00014.1         Access: Open Access Read More

Author(s): Maddineni Aruna Kumari, Chunduri Venkatarao

DOI: 10.5958/0974-4150.2020.00072.3         Access: Open Access Read More

Author(s): Arvind Lal, A. Kumar, A.K. Gupta, N.K. Yadav

DOI:         Access: Open Access Read More

Author(s): PA Jadhav, CS Raut, JP Bidada, BB Buwa, PN Dhabale, SC Dhawale

DOI:         Access: Open Access Read More

Author(s): Nachiket S. Dighe, Priyanka R. Varade, Ganesh S. Shinde, Priya S. Rao

DOI: 10.5958/0974-4150.2019.00028.2         Access: Open Access Read More

Author(s): Alka Verma, Bhupesh Verma, Sunil Kumar Prajapati, Kishu Tripathi

DOI:         Access: Open Access Read More

Asian Journal of Research in Chemistry (AJRC) is an international, peer-reviewed journal devoted to pure and applied chemistry..... Read more >>>

RNI: Not Available                     
DOI: 10.5958/0974-4150 

Popular Articles


Recent Articles




Tags