Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s
The stability of a new drug substances and new drug products is a vital parameter which may affect purity, safety & potency. Changes in drug stability can threat patient safety by formation of toxic degradation products or deliver to lower dose than expected. Therefore it is to know the purity profile & behaviour of a drug substances under the various environmental condition. Forced Degradation studies show the chemical behavior of the molecule which in turn helps in the development of new formulation & package . Degradation study is required to the design of a regulatory compliant stability program for the both drug substances & products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation studies (chemical and physical stress testing) of new chemical entities and drug product which is required to develop and demonstrate the specificity i.e stability indicating method. Forced degradation studies used to determination of the degradation pathways and degradation product of drug substances i.e during storage, development, manufacturing and packaging Thus , this review discusses the current trends in performance of forced degradation studies by provide the information about strategy for conducting the studies of forced degradation
Keywords: - Regulatory Guidelines (ICH, FDA, EMA), Degradation condition, Forced degradation, Degradation product.
2) Blessy MR, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. Journal of pharmaceutical analysis. 2014 Jun 1; 4(3):159-65.
3) Ravisankar P, Swathi V, Srinivasa Babu P, Shaheem Sultana Md GS. Current trends in performance of forced degradation studies and stability indicating studies of drugs. IOSR Journal of Pharmacy and Biological Sciences. 2017; 12(6):17-36.
4) Rawat T, Pandey IP. Forced degradation studies for drug substances and drug products-scientific and regulatory considerations. Journal of pharmaceutical Sciences and research. 2015 May 1; 7(5):238.
5) Roberto de Alvarenga Junior B, Lajarim Carneiro R. Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs. Molecules. 2019 Jan; 24(20):3804.
6) Singh S, Junwal M, Modhe G, Tiwari H, Kurmi M, Parashar N, Sidduri P. Forced degradation studies to assess the stability of drugs and products. TrAC Trends in Analytical Chemistry. 2013 Sep 1; 49:71-88.
7) Guideline ICH. Stability Testing of New drug Substances and Products. Q1A (R2), Current step. 2003 Feb.
8) FDA Guidance for Industry, INDS for Phase II and III Studies Chemistry, Manufacturing, and Controls Information, Food and Drug Administration.
9) FDA Guidance for Industry, INDS for Phase II and III Studies of drugs, Including Specified Therapeutic Biotechnology Derived Product Draft Guidance, Food and Drug Administration.
10) ICH, Final Guidance on Stability Testing of Biotechnological/ Biological Products Availability, International Conference on Harmonization.
11) ICH Guidance for Industry, Q1 B: Photo stability Testing of New Drug Substance and Product, International Conference on Harmonization.
12) FDA Guidance for Industry, Analytical Procedures and Method Validation: Chemistry, Manufacturing, and Controls Documentation, Draft Guidance, Food and Administration.
13) CDER, Reviewer Guidance: Validation of Chromatographic Method, Centre for Drug Evolution and Research.
14) ICH Guidance for Industry, Q2B: Validation Analytical Procedures: Methodology, International Conference on Harmonization.
15) L.R. Snyder, J.L. Glitch, J.J Kirkland, Practical HPLC Method Development, second ed., Wiley, New York, 1997. EMA Guideline on the Limits of Genotoxic Impurities, Committee for Medical Produces or Human Use (CHMP).
16) ICH, Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, International Conference on Harmonization, Geneva.
17) ICH, Q3B (R2): Impurities in New Drug Products, International Conference on Harmonization, Geneva.
18) FDAGuidanceforIndustry, ANDAs: Impurities in Drug Substances (draft), Food and Drug Administration, Rockville, MD.
19) FDA Guidance for Industry, ANDAs: Impurities in Drug Products (draft), Food and Drug Administration, Rockville, MD.
20) ICH Guidance for Industry, Q6B: Specifications: Test Procedure sand Acceptance Criteria for Biotechnological/ Biological Products, International Conference on Harmonization.
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